Dean Kamen

Transcription

Dean Kamen

DIA 2012
C o l l a b o ra te to I n n ova te
FINAL PROGRAM
48th Annual Meeting
June 24-28 | Philadelphia, PA
Pennsylvania Convention Center
www.diahome.org/DIA2012
Craig H. Lipset
Head of Clinical Innovation,
Worldwide Research &
Development,
Pfizer Inc
Dear Colleagues,
Michael A. Nutter
Mayor of Philadelphia
Welcome to Philadelphia and to
DIA’s 48th Annual Meeting.
Thank you for attending the DIA 2012 48th Annual Meeting.
The theme of this year’s Annual Meeting is Collaborate to Innovate. What
does this mean? It means that over the next few days you will attend and
participate in tutorials, sessions, workshops, symposia, and panel discussions to address the collaboration required among diverse partners to
bring innovative new medical products to patients.
To me, that is what the DIA Annual Meeting is all about—putting new
ideas into practice, producing rich content, offering robust networking
opportunities, and providing access to the world’s most innovative technology partners—so we can continue to make an important impact in the
delivery of new therapies to patients.
"Innovation" is a very popular buzzword, but it’s more than just good
ideas; it’s putting those ideas into practice and ultimately realizing value.
Thank you for attending the DIA 2012 Annual Meeting. I look forward to
collaborating with each of you this week.
Sincerely,
Craig H. Lipset
Program Chair
I am thrilled that the DIA 2012 48th Annual
Meeting Collaborate to Innovate is being
held right here in the Birthplace of American
Medicine. Philadelphia is the perfect setting
for your gathering. It is home to some of the
world’s most renowned institutions of higher
learning, where the best and the brightest
minds are leading the quest for new medical
discoveries and innovations.
Philadelphia is fortunate to have DIA’s
global headquarters located just a few miles
outside Center City—making it a part of the
fabric of our great city. And we share your
vision of improving health and well-being
worldwide.
While you are here in Philadelphia, please
take the opportunity to visit our cultural
attractions and historic American landmarks
and enjoy the warm hospitality of our
outstanding restaurants and the independent
spirit of our unique retail corridors.
I want to thank you for attending this year’s
DIA Annual Meeting and wish each of you a
very successful four days here in the City of
Brotherly Love.
Sincerely,
Michael A. Nutter
Mayor of Philadelphia
TABLE OF CONTENTS
4
Keynote Speaker
7
Featured Offerings
10
Networking
THE MOST PRODUCTIVE FOUR DAYS
YOU’LL HAVE ALL YEAR
22
Meeting Agenda
145
Exhibiting Companies
Schedule At-A-Glance ................................................................2
DIA 2012 Annual Meeting Tracks ............................................3
Opening Plenary Session.......................................................... 4
Ultimately, convergence is about mutual respect,
Featured Offerings in This Year’s Program ..........................5
working together, and being open to new ideas
Building Relationships Worldwide ........................................ 6
and learning from each other. To that end, DIA
Special Features ...........................................................................8
2012 provides the best opportunity to meet with
New Experiences ........................................................................ 9
people from around the world, share your views and
Networking Opportunities ......................................................10
knowledge, network, and build new relationships.
Program Committee ................................................................. 12
DIA Board of Directors ............................................................. 13
Getting Around Philadelphia .................................................. 17
General Information .................................................................. 18
Continuing Education ..............................................................20
Meeting Schedule ..................................................................... 22
Monday, June 25 ............................................................... 33
Tuesday, June 26 .............................................................. 57
Wednesday, June 27 ......................................................... 81
Thursday, June 28........................................................... 109
DIA ANNUAL MEETING MOBILE APP
Preconference Program & Tutorials.....................................117
Poster Program .........................................................................118
The DIA Annual Meeting
app is FREE and available
on Android™, iPhone®, iPad®,
as well as Mobile Web.
Download the mobile app to
access a wide range of DIA
2012 information as well as
the ability to:
Award Winners ..........................................................................121
Speaker Index ...........................................................................123
Speaker Disclosure Statements ...........................................133
Universal Activity Numbers ...................................................141
List of Exhibitors ......................................................................145
đƫ Manage your agenda
đƫ Receive news and
announcements
đƫ Network with fellow
attendees
đƫ Receive event
information in real time
Exhibitor Directory ................................................................. 150
Preconference Programs & Tutorials...................................191
Hotel Information.....................................................................201
Attendee Registration Form ................................................203
Preconference Programs & Tutorials
Registration Form.......................................................... 204
Visit the DIA booth in the Exhibit Hall for instructions or
www.diahome.org/DIA2012mobile
Exhibit Personnel Registration Form ................................205
1
DIA 2012
TUESDAY, JUNE 26
Registration Hours:
7:00 AM–4:30 PM
Collaborate to Innovate
SCHEDULE AT-A-GLANCE
7:15–8:00 AM
SATURDAY, JUNE 23
Registration Hours:
9:00 AM–5:00 PM
Attendee, Speaker, and Exhibitor Registration
Schedule:
Exhibitor Registration
SUNDAY, JUNE 24
Registration Hours:
Coffee and Breakfast Breads
8:00–9:30 AM
Concurrent Educational Opportunities
9:00 AM–3:30 PM
Exhibition Hall Open
9:30–10:00 AM
Coffee Break
10:00–11:30 AM
11:00 AM–1:30 PM
Professional Poster Session #1
11:30 AM–1:00 PM
All SIAC Luncheon Group
11:30 AM–1:30 PM
Lunch with Optional Interest Area Seating
12:00–12:45 PM
Innovation Theater Presentation: ADDPLAN PEInnovative Software for Population Enrichment Designs
in Adaptive Clinical Trials
1:30–3:00 PM
1:30–3:30 PM
Exhibit Guest Passes
3:00–3:30 PM
Refreshment Break
12:30–1:00 PM
Registration for Afternoon Preconference Program/
Tutorials
3:30–4:30 PM
4:30–6:30 PM
Adaptive Design Scientific Working Group
3:00–6:00 PM
Attendee and Speaker Registration
8:00–9:00 AM
8:00 AM–6:00 PM
Registration for Full-day, Morning Preconference
Program/Tutorials
Schedule:
WEDNESDAY, JUNE 27
8:30 AM–12:00 PM
Half-day Morning Preconference Tutorials
9:00 AM–5:00 PM
Full-day Preconference Tutorials
1:00–4:30 PM
Half-day Afternoon Preconference Tutorials
Registration Hours:
3:00–5:00 PM
Student Forum
7:00 AM–5:00 PM
Schedule:
MONDAY, JUNE 25
Registration Hours:
7:00 AM–6:30 PM
Schedule:
7:15–8:00 AM
7:15–8:00 AM
Orientation/Networking and Coffee for DIA 2012
Annual Meeting First-timers
7:15–8:00 AM
8:00–9:30 AM
9:00–3:30 PM
9:30–10:00 AM
Coffee Break
10:00–11:30 AM
11:00 AM–1:30 PM
11:30 AM–1:30 PM
1:30–3:00 PM
Opening Plenary Session
1:30–3:30 PM
9:30–10:00 AM
Coffee Break
3:00–3:30 PM
Refreshment Break
9:30–10:00 AM
Orientation and Coffee for DIA 2012 Annual Meeting
First-timers
3:30–5:00 PM
5:15–7:00 PM
Consortium of Academic Programs in Clinical Research
8:00–9:30 AM
10:00–11:30 AM
11:00 AM–6:30 PM
11:00 AM–6:30 PM
Student Poster Session
11:30 AM–1:30 PM
12:00–12:45 PM
Innovation Theater Presentation: Innovation in R&D and
Commercialization through Big Data Analytics
1:30–3:00 PM
3:00–3:30 PM
Refreshment Break
3:30–5:00 PM
5:00–6:30 PM
Welcome Reception
6:00 PM
Student Poster Award Ceremony
THURSDAY, JUNE 28
Registration Hours:
8:00–11:00 AM
Schedule:
2
8:15–9:00 AM
9:00–10:30 AM
10:30–10:45 AM
Coffee Break
10:45–12:15 PM
12:30–5:00 PM
MedDRA® User Group Meeting
DIA 2012 ANNUAL MEETING TRACKS
The DIA 2012 Annual Meeting is the largest multidisciplinary event for professionals involved in the discovery, development and
life cycle management of pharmaceuticals, biotechnology, medical devices and related health care products.
This year’s program is comprised of 22 Tracks which are related to specific interest areas as well as different formats that provide
you with new opportunities and greater flexibility.
Track #
Track Title
Related Interest Areas
Track 01
Clinical Operations
Clinical Research (CR), Research and Development (RD) Investigative
Sites (IS), Manufacturing (MF)
Track 02
Project/Portfolio Management and Strategic Planning
Project Management (PM), Financing (FI), Strategic Planning (SP)
Track 03
Innovative Partnering Models and Outsourcing Strategies
Outsourcing (OS)
Track 04
Nonclinical and Translational Development/Early Phase
Clinical Development
Biotechnology (BT), Nonclinical (NC), Pharmacology (PC)
Track 05
Product Advertising and Marketing
Advertising and Promotion (AP), Marketing (MA)
Track 06
Medical Writing and Medical Communications
Medical Writing (MW), Medical Communication (MC)
Track 07
Processes and Technologies for Clinical Research
Information Technology (IT), eClinical (EC), Clinical Data Management
(CDM), Study Endpoints (SE), Document Management (DM), Validation (VA)
Track 08
Regulatory Affairs and Submissions
Regulatory Affairs (RA), Submissions (SUBS)
Track 09
Medical Diagnostics and Devices
Combination Products (CmbP), Medical Devices and Diagnostics (MDD)
Track 10
Public Policy/HealthCare Compliance/Regulatory Law
Public Policy, Law, Corporate Compliance (PPLCC)
Track 11
Compliance to Good Clinical Practice (GCP), Good Laboratory
Practice (GLP), and Quality Assurance (QA)
Good Clinical Practices (GCP), Quality Assurance and Quality Control
(QA/QC)
Track 12
Pharmaceutical Quality
Chemistry, Manufacturing and Controls (CMC)
Track 13
Health Economics and Outcomes (HEO)/Comparative
Effectiveness Research (CER)/Health Technology
Assessment (HTA)
Comparative Effectiveness/Health Technology Assessment/Evidencebased Medicine (CEHTAEbM), Pricing and Reimbursement (PR)
Track 14
Clinical Safety and Pharmacovigilance
Clinical Safety and Pharmacovigilance (CP)
Track 15
Statistical Science and Quantitative Thinking
Statistics (ST)
Track 16
Professional Development
Professional Education, Training & Development (PETD)
Track 17
Global Regulatory
Includes program offerings hosted by a specific Regulatory Agency such
as the FDA, US; SFDA, China; European Union; PMDA, Japan; Health
Canada, Canada; etc. See page 6 for more information.
Track 18
Rare/Neglected Diseases
Rare and Neglected Diseases (RND)
Track 19
SIAC (Special Interest Area Community) Showcase
ALL
Track 20
Executive Program: Pioneering Partnerships
See page 7 for additional details
Track 21
Late-breaker
ALL
Track 22
White Paper Showcase
ALL
DIFFERENT FORMATS FOR DIFFERENT LEARNERS
FORUM: A 90-minute blended presentation and panel discussion that
includes panelists who represent diverse work settings such as regulatory,
academia, patients, and industry. Forums provide ample opportunity for
active participation by attendees.
SYMPOSIUM: A 90-minute offering consisting of several shorter presentations such as case studies and presentations from multiple perspectives.
TUTORIAL: Full- and half-day preconference tutorials are led by subject
matter experts who will provide in-depth instruction on some of today’s
hottest topics. Each preconference tutorial is designed to increase your
knowledge in specific subject areas while allowing for small group
interaction.
SESSION: A 90-minute standard lecture-style offering that includes
speakers who represent diverse work settings. Session chairs facilitate a
formal question-and-answer period.
SIAC SHOWCASE: A 60-minute presentation on a wide variety of topics
developed by DIA Special Interest Area Communities.
WORKSHOP: A 90-minute conceptual presentation delivered in an interactive/simulation or role-playing format. Workshops feature learning in
the form of activities or demonstrations.
3
OPENING PLENARY SESSION
Monday, June 25
8:00–9:30 AM
Dean Kamen is founder and president of DEKA Research &
Development Corporation. Examples of technologies developed
Terrace Ballroom
by DEKA include the HomeChoice™ Portable Dialysis Machine,
the iBOT™ Mobility System, the Segway™ Human Transporter, a
DARPA-funded robotic arm, a new and improved Stirling Engine,
and the Slingshot Water Purifier.
Dean has received many awards for his efforts, including the
National Medal of Technology in 2000 and the Lemelson-MIT
Prize in 2002. He was inducted into the National Inventors Hall of
Fame in 2005 and has been a member of the National Academy
of Engineering since 1997.
Among Dean’s proudest accomplishments is founding FIRST
Dean Kamen
Founder and President,
DEKA Research &
Development Corporation
(For Inspiration and Recognition of Science and Technology),
an organization dedicated to motivating the next generation
to understand, use, and enjoy science and technology.
Over 293,000 students and 100,000 adults
want you to discover their passion, too.
Founded by inventor Dean Kamen, FIRST® is a not-for-profit organization that designs fun, motivational,
robotics competition programs to help young people discover and develop a passion for science, engineering,
technology, and math, leading to meaningful careers in hundreds of industries. FIRST needs you to help it
continue on its blistering growth path.
To learn how to get involved in your area, please visit us today.
W W W . U S F I R S T. O R G
4
FEATURED OFFERINGS IN THIS YEAR’S PROGRAM
#139 Regulatory Collaboration/21st Century Innovation: Views of the Heads of Health Canada,
the European Medicines Agency, and the US FDA
Co-Chair:
Marie Allison Dray, MA, MBA
International Regulatory
Affairs Group LLC
Paul Glover, MBA
Health Canada
Margaret A. Hamburg, MD
FDA
MONDAY, 1:30–3:00 PM
Room: 120 bc
Guido Rasi, MD
European Medicines Agency,
European Union, UK
Co-Chair:
Murray M. Lumpkin, MD,
MSc
FDA
#208 Meta-collaborations: A Call to Action
Chair:
Freda Lewis-Hall, MD
Pfizer Inc
TUESDAY, 8:00–9:30 AM
Room: Terrace 4
Kathy L. Hudson, PhD
National Institutes of
Health
Margaret A. Anderson, MS
FasterCures
#245 Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion
Chair:
Ed Silverman
Pharmalot
TUESDAY, 1:30–3:00 PM
Room: 121 ab
Paula Brown Stafford,
MPH
Quintiles
Jeffrey P. McMullen
PharmaNet/i3, an inVentiv
Health Company
Douglas J. Peddicord, PhD
Association of Clinical
Research Organizations
William J. Sharbaugh,
MA, MSc
PPD
Josef von Rickenbach, MBA
PAREXEL International
John Watson
Covance Inc.
#330 Partnering for Impact in Global Health
Chair:
Nicole Bates, DrPH
Bill & Melinda Gates
Foundation
Stephen P. Spielberg, MD,
PhD
FDA
WEDNESDAY, 10:00–11:30 AM
Room: 121 ab
Vincent I. Ahonkhai, MD
Foundation
Ken Duncan, PhD
Foundation
Amrit Ray, MD, MBA
Janssen Research &
Development, LLC
David Reddy, PhD
Medicines For Malaria
Venture (MMV)
Switzerland
#397 Implementation of the Physician Payment Sunshine Act: Now What?
Chair:
John F. Kamp, JD, PhD
Coalition for Healthcare
Communication
Daniel Carlat, MD
Pew Prescription Project
Sandra J. P. Dennis, JD
Biotechnology Industry
Organization (BIO)
Marjorie E. Powell, JD
PhRMA
Thomas P. Stossel, MD
Brigham & Women’s
Hospital
5
WEDNESDAY, 3:30–5:00 PM
Room: 122 b
John J. Lewis, MA
Association of Clinical
Research Organizations
BUILDING RELATIONSHIPS WORLDWIDE
As of May 1, 2012
One of the unique features of the DIA 2012 Annual Meeting is the Global Regulatory Track that includes 15 program
offerings led by a variety of global and regional regulatory agencies. Attend any of the following offerings and learn
from key officials and have the unique experience to have your questions answered.
MONDAY, JUNE 25
#120
European Town Hall: Part 1 of 2 – Hot Topics in Europe
113c
#121
Pediatric Drug Development Progress: 15 Years Later and
Across the Globe
116
#148
European Town Hall: Part 2 of 2 – Interacting With the
European System
120bc
#174
An Update on EMA, FDA, and PMDA International
Activities
113b
GOVERNMENTAL AGENCIES
đƫ Agency for Healthcare Research and Quality
(AHRQ), US
đƫ Administración Nacional de Medicamentos, Alimentos y
Tecnología Médica (ANMAT), Argentina
đƫ National Health Surveillance Agency (ANVISA), Brazils
đƫ Austrian Medicinal and Medical Device Agency
(AGES), Austria
TUESDAY, JUNE 26
#237
International Regulatory Cooperation: A Canadian
Perspective
116
đƫ Federal Institute for Drugs and Medical Devices
(BfArM), Germany
#238
Latin America Town Hall
117
đƫ Center for Drug Evaluation (CDE), Taiwan
#260
Update from the EMA-FDA Parallel Assessment Pilot
122b
#261
SFDA Town Hall
117
đƫ Central Drugs Standard Control Organization (CDSCO),
India
đƫ The Federal Commission for the Protection against
Sanitary Risk (COFEPRIS), Mexico
WEDNESDAY, JUNE 27
#324
Risks to and Securing of Global Drug Supply Chains
115a
#368
Pharmaceuticals and Medical Devices Agency (PMDA)
Town Hall
122b
#369
CBER Town Hall
119a
đƫ Food and Drug Administration (FDA), US
#394
The State of Electronic Submissions at CDER, CBER, and
CDRH
121ab
đƫ Federal Agency For Medicines and Health Products
(FAMHP), Belgium
#395
India Town Hall
119a
đƫ Food and Drug Administration (FDA), Department of
Health, Taiwan
đƫ Department of Justice (DOJ), US Attorney’s Office, US
đƫ European Medicines Agency, European Union, EU
THURSDAY, JUNE 28
đƫ Health Canada
#413
CDER Town Hall: Part 1 of 2
114
đƫ Health and Human Services (HHS), US
#425
114
đƫ National Authority of Medicines and Health Products
(INFARMED), Portugal
đƫ Instituto de Salud Publica de Chile (ISPCH), Chile
đƫ Italian Medicines Agency (AIFA), Italy
đƫ Medicines and Healthcare products Regulatory Agency
(MHRA), UK
đƫ Medicines Evaluation Board (MEB), Netherlands
đƫ Ministry of Health, Labour and Welfare (MHLW), Japan
đƫ National Institute of Aging, NIH, US
đƫ National Institutes of Health (NIH), US
đƫ National Library of Medicine, NIH, US
đƫ The New Partnership for Africa's Development
(NEPAD), South Africa
đƫ Office of the Secretary, DHHS, US
đƫ Pharmaceuticals and Medical Devices Agency
(PMDA), Japan
đƫ State Food and Drug Administration (SFDA), China
đƫ Therapeutic Goods Administration (TGA), Australia
đƫ US Army Medical Research and Material Command
(USAMRMC), US
6
Building Relationships Worldwide
ACADEMIC INSTITUTIONS AND STAKEHOLDER ORGANIZATIONS
(Program Offering Number)
As of May 1, 2012
đƫ Alagille Syndrome Alliance (#396)
đƫ Pew Prescription Project (#397)
đƫ Alfred Mann Biomedical Engineering Institute (#404)
đƫ Pharmaceutical Advertising Advisory Board (PAAB),
Canada (#354)
đƫ American Association For Cancer Research (#222)
đƫ Prescription Medicines Code of Practice Authority
(PMCPA), UK (#354)
đƫ Bill & Melinda Gates Foundation (#330)
đƫ Brigham & Women’s Hospital (#397)
đƫ SAPA (Sino-American Pharmaceutical Professionals
Association) (#137)
đƫ Campbell University College of Pharmacy and Health
Sciences (#373)
đƫ Children’s Hospital Colorado (#396)
đƫ Seoul National University Hospital, Republic of Korea
(#166)
đƫ Children’s Mercy Hospitals and Clinics (#221)
đƫ Shanghai Clinical Research Center (SCRC), China (#155)
đƫ Childrens National Medical Center (#346)
đƫ Technical University of Denmark (#377)
đƫ CINECA Inter-University Consortium, Italy (#381)
đƫ Temple University (#316)
đƫ Columbia University (#257)
đƫ The University of Texas (#423)
đƫ Dana-Farber Cancer Institute (#204)
đƫ Duke Clinical Research Institute (#117, #353, #378)
đƫ Tufts Center for the Study of Drug Development
(#362, #405)
đƫ Duke Institute for Genome Sciences and Policy (#378)
đƫ Tufts University (#103, #219, #247, #374)
đƫ Duke University Medical Center (#204, #274)
đƫ Tufts University School of Medicine
đƫ Eastern Michigan University (#259, #323)
đƫ University of Alabama at Birmingham (#259)
đƫ Erasmus University Medical Center, Netherlands (#257)
đƫ University of Amsterdam, Netherlands (#389)
đƫ Farmaindustria, Spain (#354)
đƫ University of Maryland University College (#392)
đƫ FasterCures (#208)
đƫ University of Medicine and Dentistry of New Jersey
đƫ Harvard Medical School (#143)
đƫ University of Nebraska Medical Center (#331)
đƫ Harvard Pilgrim Health Care Institute (#321)
đƫ University of North Carolina at Chapel Hill (#118)
đƫ Inter-American Foundation for Clinical Research (IAFCR)
(#259, #323)
đƫ University of North Carolina School of Public Health
(#143)
đƫ International Cancer Advocacy Network (#312)
đƫ University of Pennsylvania (#319)
đƫ International Partnership For Microbicides, South Africa
(#119)
đƫ University of the Sciences in Philadelphia
đƫ International Society For Translational Medicine (ISTM),
Austria (#119, #204)
đƫ Virginia Commonwealth University
đƫ University of Washington (#335)
đƫ Keio University, Japan (#233, #385)
đƫ London School of Economics, UK (#108, #172)
đƫ Massachusetts Institute of Technology (MIT) (#383)
đƫ Mayo Clinic (#334)
đƫ Medical College of Wisconsin (#258)
Presents the DIA 2012 Annual Meeting Executive Program:
Pioneering Partnerships
đƫ Medical University of Vienna, Austria (#353)
đƫ Medicines For Malaria Venture (MMV), Switzerland
(#330)
TUESDAY, JUNE 26
10:00–11:30 AM
Collaborative Research with Members of the Payer
Community
đƫ Multiple Myeloma Research Foundation (#306)
đƫ National Health Council (#312)
12:00–1:30 PM
Challenges of Precision Medicine: Diagnostics,
Reimbursement, and Parnership Co-development
đƫ National Organization For Rare Disorders (NORD)
(#359, #370)
đƫ National Pharmaceutical Council (#319)
Visit Speaker Registration for more information.
đƫ Nattokushite Iryou Wo Ukerukai, Japan (#385)
7
SPECIAL FEATURES
ROLE OF PATIENTS IN DRUG DEVELOPMENT
DIA understands that patients play a key role in the drug development
process. Clinical trials help to pinpoint the areas where pharma professionals
need to learn more to advance scientific and patient innovation. DIA provides
the perfect forum for patients not only to network with and learn from
experts from around the world but also to participate in the process of
bringing safe and effective therapies to market.
with policymakers, industry, academia, and health professionals by taking
part in all facets of DIA 2012 Annual Meeting. The conference provides a
forum for sharing best practices, stimulating cooperation, and facilitating a
two-way dialogue across the entire global healthcare community.
To join the conversation about the patient perspective, look for the Patient
Fellowship tables in the networking lunch area and visit the Patient
Advocate Fellowship Booth #1513 for a chance to win a free registration to
Twenty-one patient representatives, chosen through a competitive process,
will have opportunities to develop, strengthen, and support collaborations
the DIA 2013 Annual Meeting, June 23–27, Boston, MA! PATIENT ADVOCATE FELLOWSHIP ORGANIZATIONS
Ovarian Cancer
National Alliance
We work to save women’s lives
DIA 2012 RESOURCE CENTER
GET INVOLVED BOOTH
Learn more about DIA’s online educational programs by visiting the DIA
2012 Resource Center! Explore DIA’s eLearning modules, online training
courses, and live and archived webinars throughout the day at your own
pace, or take advantage of demonstrations highlighting these products.
"Meet the Expert" sessions will also be available during lunch each day.
Stop by the Get Involved Booth located in the Meeting Room Concourse
đƫ Learn more about DIA Volunteer Opportunities
đƫ See a demonstration of the DIA ConneX tool for global Special
Interest Area Communities (SIAC) communications
Join a Community Today!
A schedule of demonstrations and "Meet the Expert" sessions can be
found in the Show Daily and on the DIA 2012 Mobile App.
The DIA Resource Center is located at the DIA booth. We look forward
to seeing you there!
8
NEW EXPERIENCES
COMPANY WHITE PAPER SHOWCASE
LIFE SCIENCE ENTREPRENEUR PAVILION
Learn from the experts in this newly formed track called the White Paper
Showcase. Eight companies will lead their own Showcase where they will
highlight their company expertise and solutions in this year’s program.
Location: Exhibit Hall
Be sure to visit the Life Science Entrepreneur Pavilion, located in the Poster
area of Exhibit Hall D, where innovative companies and entrepreneurs will
be available to discuss how they are changing the future development of
new medicines.
MONDAY, JUNE 25
#124 The New Health Report 2012: Rethinking the Risk Equation in
Biopharmaceutical Development and Delivery
#150 Free Agency is Here: Exploring Workforce Impact on Clinical
Outsourcing
Pfizer is pleased to support the Life Science Entrepreneur Pavilion at the
DIA 2012 Annual Meeting.
#175 Raising the Bar for Regulatory Submission Document Quality:
A Collaborative, Transitional Approach
INNOVATION THEATER PRESENTATIONS
Location: Exhibit Hall
Take advantage of lunch time presentations in the Innovation Theater.
Monday, June 25, 12:00–12:45 PM
TUESDAY, JUNE 26
Innovation in R&D and Commercialization through Big Data Analytics
#239 Value of Actigraphy in Clinical Trials
Developed by EMC Corporation, also host of the Monday afternoon
refreshment break.
#264 The Unique Relationship between Global Patient Recruitment and
Translation Management
a DIA 2012 Annual Meeting Level I Supporter
Monday, June 25, 5:30–6:00
PM
Empowering Clinical Research & Development of Tomorrow
Developed by iGate
WEDNESDAY, JUNE 27
#325 Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites
a DIA 2012 Annual Meeting Level 1 Supporter
Tuesday, June 26, 12:00–12:45
PM
ADDPLAN PE- Innovative Software for Population Enrichment Designs in
Adaptive Clinical Trials
#371 Implementation of Adaptive Clinical Trials
Developed by Aptiv Solutions.
#398 Accelerating Cancer Clinical Trials
Additional presentations will be announced in the Show Daily
and via the DIA Annual Meeting Mobile App.
9
NETWORKING OPPORTUNITIES
JOIN A COMMUNITY!
Meet colleagues who share your professional interests, experience and knowledge
đƫ Network with specialists you wouldn’t normally meet
đƫ Stay on the pulse of hot topics and shared learning
đƫ Broad choice of specialized communities
ALL SIAC LUNCH (Special Interest Area Communities)
TUESDAY, JUNE 26, 11:30 AM–1:00 PM
TERRACE BALLROOM II
Reaching Around the World to Create a Global Community
Open to all current SIAC members and all attendees interested in learning more about
DIA Communities
SIACs
đƫ Biotechnology & Innovative Preclinical
Sciences
đƫ Investigator & Investigative Sites
đƫ Chemistry, Manufacturing & Controls &
Quality System
đƫ Marketing & Sales
đƫ Clinical Data Management
đƫ Clinical Pharmacology
đƫ Clinical Research
đƫ Clinical Safety & Pharmacovigilance
đƫ Clinical Trial Disclosure
đƫ Legal Affairs
đƫ Medical Communications
đƫ Medical Writing
đƫ Medical Science Liaison
đƫ Natural Health Products
đƫ Pediatric
đƫ Devices & Diagnostics
đƫ Professional Education, Training &
Development
đƫ Document & Records Management
đƫ Project Management
đƫ eClinical
đƫ Quality Risk Management
đƫ Electronic Regulatory Submissions
đƫ Regulatory Affairs
đƫ Emerging Professionals
đƫ Statistics
đƫ Evidence Based Medicine
đƫ Study Endpoints
đƫ Global Sourcing
đƫ Validation
đƫ Good Clinical Practices & Quality Assurance
đƫ Information Technology
SIAC Showcase:
The SIAC Showcase is an opportunity to attend a content-based offering developed to highlight the
expertise of each SIAC to the attendees of the DIA 2012 Annual Meeting. The SIAC Showcase also
highlights the benefits of networking with professionals who share the same responsibilities, disciplines
and interests. Please see the SIAC Showcase sessions listed in the program on Tuesday, June 26 from
3:30–4:30 PM.
DISCOVER NEW BUSINESS
VENTURES AND UNLOCK
PRIZES
500 chances to win one of 100 prizes.
The more exhibitors you visit, the more chances
you have to win!
Prizes include
đƫ New iPads
đƫ Microsoft Xbox 360 and Kinect
đƫ Wii
đƫ Free Registration to the DIA 2013
Annual Meeting
đƫ And much more!
Be sure to ask each exhibitor you visit for a key to
unlock the fun at DIA 2012!
10
Networking Opportunities
The DIA 2012 Annual Meeting attracts the biggest names from the pharmaceutical, biotechnology, medical device, and related
sectors, and features key networking opportunities.
FIRST-TIMER ORIENTATION
LUNCH HOURS IN EXHIBIT HALL
Is this your first time at the DIA Annual Meeting? DIA 2012 includes two
opportunities to learn how to optimize your experience at DIA 2012. The
first offering includes a Speed Networking opportunity. Bring your business
cards to network with fellow Annual Meeting first-timers and learn how to
make the most of your Annual Meeting experience.
Enjoy extended lunch hours to visit more than 550 exhibiting companies in
the exhibit hall.
đƫ Monday–Wednesday, June 25–27, 11:30 AM–1:30 PM
Monday, June 25, 7:15–8:00 AM
đƫ Includes Speed Networking
Monday, June 25, 9:30–10:00 AM
Take advantage of this special seating area that allows you to eat and
network with colleagues of the same interest. This seating area is located in
the exhibit hall, and will be organized by DIA 2012 tracks. See Floor Plan on
the back of the Exhibits tab in this program for exact location.
REFRESHMENT BREAKS
DIA WELCOME RECEPTION
Meet with your colleagues to plan your day and discuss what you learned
the day before, all while networking with other attendees each morning in
the meeting room concourse of the Convention Center. Midmorning and
mid-afternoon breaks will also be held in designated areas of the Exhibit Hall.
Monday, June 25, 5:00–6:30 PM
NETWORKING LUNCH AREA
We invite you to network with nearly 7,500 attendees at the DIA Welcome
Reception in the exhibit hall. See old friends and make new acquaintances,
while visiting more than 550 exhibiting companies. While you browse, be
sure to use the complimentary beverage coupon which is included in the
badge envelope for all non-exhibiting participants.
See Schedule At-A-Glance on page 2 for break times.
Monday afternoon break supported by:
Reception hosted by DIA with support from:
also a DIA 2012 Annual Meeting Level I Supporter
STUDENT FORUM
Sunday, June 24, 3:00–5:00 PM, Room 125
The Student Forum provides real-world information to students and offers
them an opportunity to speak with DIA volunteers and representatives. For
more information on the Student Forum see page 33.
STUDENT POSTER SESSION
Monday, June 25, 11:00 AM–6:30
PM
Join us in Exhibit Hall D as we showcase posters by students from around
the world. An awards ceremony will be held at 6:00pm to award the first-,
second-, and third-place student poster winner.
See page 118 for a listing of student posters.
PROFESSIONAL POSTER SESSIONS
Location: Exhibit Hall D
A selected group of professional poster presenters will share their research
results in various topics. There will be two dedicated times with different
posters available for view.
See page 118 for a listing of professional posters.
đƫ Session #1 Tuesday, June 26, 11:00 AM–1:30 PM
đƫ Session #2 Wednesday, June 27, 11:00 AM–1:30 PM
11
DIA 2012 ANNUAL PROGRAM COMMITTEE
Solomon Babani, MBA
Celtic Pharma
Therapeutics Services
Chuck Drucker, MBA
Covance Inc.
Jeff Litwin, MD
ERT
Kim M. Quaintance
Eisai, Inc.
Roy Baranello, MS
ViroPharma Incorporated
Lauren Edelstein Henry,
MEd
Janssen Pharmaceutical
Companies of Johnson &
Johnson
Barry Mangum, PharmD
Duke University Medical
Center
Stephen A. Raymond, PhD
PHT Corporation
Annetta Beauregard,
MBA, MS
EMD Serono, Inc.
Fritz Erni, PhD
Consultant
Christopher M. Marrone,
PharmD
Eli Lilly and Company
Margaret S. Richards, PhD
PPD
Bruce Binkowitz, PhD
Merck Research
Laboratories
Kathleen Findlen
Collegium
Pharmaceutical
Munish Mehra, PhD
Quantum Biopharma
Janet L. "Lucy" Rose,
MBA
Lucy Rose and
Associates, LLC
Larry Blankstein, PhD
Genzyme Corporation
J. Michael Fitzmaurice,
PhD
Agency for Healthcare
Research and Quality
Sandra A. Milligan,
JD, MD
Genentech, Inc.
Gregg Schneider
Otsuka Pharmaceutical
Kay Bross, MEd
Interop.KBross
Consulting, LLC
Mary Gardner Stewart,
MSc
H. Lundbeck A/S
C. Latham Mitchell, MD
Erudita Biotechnical LLC
Leigh Shultz, MD
Merck & Co., Inc.
Paul Brown, PhD
FDA
Natalie C. Gearhart,
PharmD
Ortho-McNeil Janssen
Scientific Affairs LLC
Christine M. V. Moore,
PharmD
FDA
Janet Stoltenborg, MBA
AstraZeneca
Pharmaceuticals LP
Joan K. Buenconsejo,
PhD, MPH,
FDA
Alan M. Hochberg
F. Hoffman-La Roche Ltd.
Cecil J. Nick, MS
PAREXEL Consulting
Patrick Thomas, MS
GlaxoSmithKline
Nancie E. Celini, MPH,
DrPH
CAB Inc.
Christopher J. Hoyle, MBA
Elite Research Network
Frances E. Nolan, MBA
Medidata Solutions
Worldwide
Melonie Warfel
Pegasystems Inc.
Anne Cropp, PharmD
Pfizer Inc
Nirdosh Jagota, PhD
Genentech, Inc.,
A Member of the Roche
Group
Catherine
Ohura, MS, PMP
Bristol-Myers Squibb
Company
Keith W. Wenzel
Perceptive Informatics
Nancy Dreyer, PhD, MPH
Outcome
Chin Koerner, MS
Novartis Pharmaceuticals
Corporation
Shaghig Palanjian, MBA
Shire Human Genetic
Therapies, Inc.
12
PROFESSIONAL AND STUDENT POSTERS CHAIRS
James Parmentier, PhD
University of Medicine
and Dentistry of New
Jersey
Carolynn J. Thomas-Jones,
MPH
University of Alabama at
Birmingham
Albert Wertheimer, PhD,
PharmD, MBA
Temple University School
of Pharmacy
Leah A. Christl, PhD
FDA
Martin Harvey-Allchurch,
LLM
European Medicines
Agency, EU
Agnes V. Klein, DrPH, MD
Health Canada
Tatsuo Kurokawa, PhD
Keio University, Faculty of
Pharmacy, Japan
Ling Su, PhD BeijingNovartis
Pharma Co., Ltd., China
Jürgen Venitz, PhD, MD
Virginia Commonwealth
University
Barbara Gladson, PhD, MS
University of Medicine
and Dentistry of New
Jersey
PROGRAM ADVISORS
2011/2012 DIA BOARD OF DIRECTORS
President
Directors
Yves Juillet, MD
Industrie Santé, France
President-Elect
Ling Su, PhD
Beijing Novartis Pharmaceutical Co., Ltd., China
Treasurer
Minnie Baylor-Henry, JD
Johnson & Johnson Medical Devices and
Diagnostics
Immediate Past President
Richard Osborne Day, AM, MB, MD, FRACP
St. Vincent's Hospital
University of New South Wales, Australia
Steve Caffé, MD
MedImmune, the Global Biologics Unit of
AstraZeneca
Jennifer L. Riggins, PharmD
John A. (Jay) Roberts, MBA
AdvantEdge Healthcare Solutions
Sergio Guerrero, MD
Accelerium Clinical Research, Mexico
Larisa Nagra Singh, MPharm
Quintiles, India
Truus Janse-de Hoog, PharmD
Medicines Evaluation Board, The Netherlands
Per Spindler, DVM, MBA, MSC
BIOPEOPLE – University of Copenhagen,
Denmark
Keio University, Faculty of Pharmacy, Japan
RADM Sandra L. Kweder, MD
FDA
Michele Livesey, MBA
Livesey Consulting
Sandra A. Milligan, JD, MD
Genentech, Inc.
Beat Widler, PhD
Widler & Schiemann Ltd., Switzerland
Ning Xu, MD, MBA
Covance, China
Jean Yager, PhD
We look forward to seeing you
in Boston!
DIA 2013 Advancing Therapeutic
Innovation & Regulatory Science
49th Annual Meeting,
June 23–27, 2013
Photo Courtesy of Greater Boston Convention
& Visitors Bureau.
Photo Courtesy of Greater Boston Convention & Visitors Bureau.
13
CONTENT PARTNERS
DIA WOULD LIKE TO THANK OUR CONTENT PARTNERS!
SAPA
Philadelphia
www.sapa-gp.org
MEDIA PARTNERS
DIA WOULD LIKE TO THANK OUR MEDIA PARTNERS!
www.gabionline.net
GaBI
O n l i n e
TM
GENERICS AND
BIOSIMILARS
INITIATIVE
Building trust in cost-effective treatments
PharmaTimes
14
THANK YOU TO OUR DIA 2012 ANNUAL MEETING SUPPORTERS!
LEVEL 2
LEVEL 1
SOCIAL MEDIA
STAY CONNECTED!
GET THE BIG PICTURE WHILE YOU ARE AT DIA 2012!
For everything DIA 2012. . .
Follow us @DrugInfoAssn
Get real-time announcements and updates.
Have a question? Follow us and ask.
Official hashtag is #DIA2012.
Follow us at DrugInfoAssn
Be your own paparazzi. Share your photos with us.
Join our group at Drug Information Association (DIA) —
Biopharmaceutical Professionals.
Stay engaged with new announcements on hot topics,
new speakers and networking events.
DrugInfoAssoc
Watch videos from DIA 2012 and past Annual Meetings.
“Like” Us at DrugInfoAssn
Post your experience on DIA’s wall.
Share your photos from DIA 2012.
Check-in to DIA 2012.
DIA ANNUAL MEETING MOBILE APP
The DIA Annual Meeting
app is FREE and available
on Android™, iPhone®, iPad®,
as well as Mobile Web.
Download the mobile app to
access a wide range of DIA
2012 information as well as
the ability to:
đƫ Manage your agenda
đƫ Receive news and
announcements
đƫ Network with fellow
attendees
đƫ Receive event
information in real time
Visit the DIA booth in the Exhibit Hall for instructions or
www.diahome.org/DIA2012mobile.
15
EXPERIENCE THE CHARM
OF PHILADELPHIA!
We hope you find some time to tour Philadelphia and
discover what makes America’s most historic city so cutting
edge. Visit www.philadelphiausa.travel for details about:
WHAT’S FREE
Check out the free events held throughout the city, including historic sites
such as Elfreth’s Alley, the Liberty Bell Center, and much more.
CUISINE
Dine on some of Philadelphia’s most well-known delicacies such as cheesesteaks, soft pretzels, and Tastykakes, but don’t be shy about sampling new
cuisine—from classic to contemporary. Visit www.philadelphiausa.travel for
complete details.
SHOW YOUR BADGE DISCOUNTS
Show your room key or DIA 2012 Annual Meeting badge to many vendors,
shops, and restaurants around the city to receive special discounts exclusively for DIA Annual Meeting attendees.
PHILLY ON THE MOVE
Download the Philadelphia Convention & Visitors Bureau
mobile app at www.philadelphiausa.mobi to help you
navigate the city, and find information on attractions, dining
options, nightlife and events.
TOUR PROGRAM
Philadelphia Sightseeing Tours, Inc. will be available in the Exhibit Hall
D Lobby, offering attendees a full range of fully-guided, entertaining,
discounted tours of Philadelphia, "the most historic city in America". Tour
desk hours are: Monday, 9:30 AM–6:30 PM; Tuesday, 9:30 AM–3:30 PM; and
Wednesday, 9:30 AM–1:30 PM. To see the full tour program and to guarantee
your selection, you can register online by going to www.diahome.org/
DIA2012, and click on Networking, or simply stop by the tour desk during
the hours noted above.
16
Philadelphia
GETTING AROUND
PHILADELPHIA
BY PUBLIC TRANSIT
SEPTA Rail Lines service the entire Philadelphia Region. The Market East
Station is connected to the Convention Center. The Airport Line connects
PHL directly to downtown Philadelphia in just 20 minutes. (To get to
the Pennsylvania Convention Center, disembark at Market East Station.)
From Amtrak’s 30th Street Station, take the SEPTA Regional Rail to the
Convention Center. A regional rail train departs every few minutes. With
your Amtrak ticket, the ride to Center City is free. Other SEPTA Regional
Rail Lines can shuttle you throughout the region. Please visit www.SEPTA.
org or call +1.215.580.7800.
BY TAXI
Taxis are readily available to/from the airport. Taxis will depart and pick-up
from 12th and Arch Streets. All taxi rates are applied on a per-trip basis, not
per person. Most taxis can accommodate up to three passengers. In some
cases, certain vehicle types can accommodate four passengers. There is a
flat rate of $28.50 from the airport to Center City, not including optional
gratuity.
DIA COURTESY SHUTTLE
You must have verification that you are staying at one of the room block
hotels listed below in order to board the DIA Shuttle. A decal, which you
will need to apply to your name badge, will be given to you when you check
in at your hotel. Please have this decal with you when you are boarding the
bus to go to the convention center, and attach it to your name badge which
you will pick up at registration. If the hotel does not provide you with the
decal at check in, you can stop at the Housing Desk, located in the Broad
Street Lobby, and one will be provided to you after verifying your registration at one of these hotels.
The following hotels will be provided with a DIA courtesy shuttle to and
from the convention center in the morning and at the conclusion of each
day’s events.
đƫ Crowne Plaza Downtown – 1800 Market Street
đƫ Doubletree Philadelphia – 237 South Broad Street
đƫ Embassy Suites City Center – 1776 Ben Franklin Parkway
đƫ Four Seasons Philadelphia – One Logan Square
đƫ Holiday Inn Express Midtown – 1305 Walnut Street
đƫ Hotel Palomar – 117 South 17th Street
đƫ Hyatt at the Bellevue – 200 South Broad Street
đƫ Radisson Plaza Warwick – 1701 Locust Street
đƫ Ritz Carlton – 10 Avenue of the Arts
đƫ Sheraton Downtown – 201 North 17th Street
đƫ Sofitel Philadelphia – 120 South 17th Street
đƫ Westin Philadelphia – 99 South 17th Street
The following hotels are within walking distance of the convention center
and will not offer shuttling.
đƫ Courtyard by Marriott – 21 North Juniper Street
đƫ Four Points by Sheraton City Center – 1201 Race Street
đƫ Hampton Inn City Center – 1301 Race Street
đƫ Hilton Garden Inn City Center – 1100 Arch Street
đƫ Le Meridien Philadelphia – 1421 Arch Street
đƫ Loews Philadelphia – 1200 Market Street
Philadelphia photography by Andrea Burolla, Tim Hawk, Bob Krist,
Paul Loftland, Richard McMullin, Edward Savaria, Miles Weaver, and
bklphoto.com for the PCVB.
17
GENERAL INFORMATION
ACCESSING PRESENTATIONS
CYBER CAFÉ AND RECHARGE STATION
During the meeting, available presentations are accessible via DIA’s Live
Learning Center to full conference and one-day registrants*. Please note
that this does not include all of the presentations but those that were provided to DIA prior to the start of the Annual Meeting.
DIA is providing workstations in meeting rooms 108 and 119 concourses for
those who do not have laptop computers or other devices.
New this Year! Electric recharge stations are available adjacent to the workstation areas.
Post meeting audio synchronized presentations will be available to fullconference and one-day registrants* within 2 weeks after the conference.
All applicable registrants will be notified by email when the postings are
complete. Access to the DIA’s Live Learning Center is FREE for a period of 6
months post conference. After this 6 month period, access to the meeting recordings will be available for purchase. Please note that due to their
interactivity format, workshops will not be recorded.
DRESS CODE
Dress code is business casual. Neckties, business suits, or other business
attire are acceptable, but not necessary. The Convention Center may be
chilly so bring a sweater or jacket; comfortable shoes are a must!
EXHIBITOR LOCATOR
Demonstrations on how to access presentations via the DIA’s Live Learning
Center will be available at the DIA Booth in the Exhibit Hall.
Search for an exhibiting company by company name, keyword, or service.
Exhibitor Locator workstations will be available inside the entrances to
Exhibit Halls C and D.
To access available presentations, visit the DIA’s Live Learning Center at
www.diahome.org/DIA2012LLC
FIRST AID CENTER
If you experience technical difficulties, please contact DIA’s Live Learning
Center at +1.888.711.1138, extension 5400, or multiviewmediasupport@
multiview.com.
First Aid is available for routine health problems and emergency care.
The First Aid Center is located on the Exhibit Hall level, near the entrance
to Exhibit Hall D. In case of emergency dial 4911 from any house phone or
215-418-4911 from your cell phone and provide the location of your emergency. Pennsylvania Convention Center Security will dispatch medical
personnel at once. Please do not dial 911.
*One-day registrants will have access to PowerPoint presentations that
occur on the day for which you are registered.
BAGGAGE CHECK
INFORMATION BOOTH
An area of the Broad Street Lobby is available for attendees to check their
belongings if necessary. The Baggage Check Area will be available as follows:
Sunday, June 24
Monday, June 25
Tuesday, June 26
Wednesday, June 27
Thursday, June 28
A DIA Information Booth will be located in the meeting room concourse
near room 120. Should you have any questions throughout the event, please
visit the booth for assistance. The Information Booth can also be reached by
phone at 215-418-2400 during event hours.
8:00 AM–5:30 PM
7:00 AM–7:00 PM
7:00 AM–5:00 PM
7:00 AM–5:30 PM
8:00 AM–12:30 PM
LOST & FOUND
Note: There will be a $2.00 fee for each bag checked. All items checked
must be collected by the close of the Baggage Check Area each day.
DIA is not responsible for items left in the Baggage Check Area.
Misplaced items will be stored at the DIA Information Booth, located in the
meeting room concourse near room 120, until the end of the event. Items
remaining at the close of the DIA 2012 Annual Meeting will be turned over
to the Pennsylvania Convention Center Security.
BUSINESS CENTER
At that point, you can contact the Pennsylvania Convention Center at
215-418-4700.
FedEx is the official business center for the Pennsylvania Convention Center,
providing full service business needs. The FedEx office retail storefront
is located inside the Pennsylvania Convention Center on the 200 level,
between Exhibit Halls B & C. It will be open throughout DIA 2012, Sunday
through Wednesday, 8:00 AM–5:00PM, and Thursday, 8:00 AM–1:00 PM. The
phone number is 215-925-1218 and fax is 215-925-3738.
LUNCH VOUCHER PROGRAM
In order to provide you with a variety of food options and freedom of choice,
a voucher program is being used for DIA’s luncheon service. Your vouchers
were included in your badge envelope that you received when you registered. Please keep your vouchers in a safe place, as replacement vouchers
will not be issued. The voucher is redeemable for up to $15 (inclusive of tax)
for food and beverage items, and must be provided at checkout.
CAREER CENTER
DIA’s interactive Career Center, located on the meeting room concourse, is
your premier resource for online employment connections!
Looking for the perfect fit? The DIA Career Center offers employers
targeted access to quality industry professionals, quick and easy job
posting, online job activity reports, and access to the National Healthcare
Career Network of over 60 top healthcare associations and professional
organizations.
Lunch vouchers are not redeemable for cash, and change will not be provided if your purchase is under $15.00. Only one voucher can be used per
transaction and they are not transferable. Therefore, each participant will
need to pick up his or her own lunch. Vouchers can be used in the exhibit
hall only, and are valid between the hours of 11:30 AM and 1:30 PM, Monday,
Tuesday, and Wednesday.
Job seekers receive FREE and confidential resume posting, automated
weekly email notification of new job listings, and the ability to save jobs for
later review.
In order to expedite your lunch service each day, please reference the lunch
voucher flyer included in your registration bag.
To find a job or fill a position, visit www.diahome.org/DIACareerCenter.
MISPLACED YOUR BADGE?
Participants will incur a $25 fee for badge reprints. If you require a badge
reprint, please visit the Cashier at Attendee Registration, located in the
Broad Street Lobby. Identification will be required.
18
General Information
POSTER SESSIONS
RESTAURANT INFORMATION BOOTH/
CITY INFORMATION
The student and professional poster sessions, located in Exhibit Hall D,
provide an excellent opportunity for presenters to share their research
results with attendees.
Philadelphia is such a food lovers paradise that you will face just one dilemma;
how to choose from so many options? The Pennsylvania Convention and
Visitors Bureau wants to help you make the most of your dining experience
in Philadelphia. To find Philadelphia best dining options, stop by the City
Information/Restaurant Booth located in the Broad Street Lobby.
The posters present scientific developments related to the topics addressed
in Annual Meeting Tracks.
Student Poster Session:
Monday, June 25, 11:00 AM–6:30 PM
Professional Poster Session #1: Tuesday, June 26, 11:00 AM–1:30 PM
Professional Poster Session #2: Wednesday, June 27, 11:00 AM–1:30 PM
TOUR PROGRAM
Philadelphia Sightseeing Tours, Inc. will be available in the Exhibit Hall
D Lobby, offering attendees a full range of fully-guided, entertaining,
discounted tours of Philadelphia, "the most historic city in America". Tour
desk hours are: Monday, 9:30 AM–6:30 PM; Tuesday, 9:30 am–3:30 pm; and
Wednesday, 9:30 AM–1:30 PM. To see the full tour program and to guarantee
your selection, you can register online by going to www.diahome.org/
DIA2012 and click on Networking, or simply stop by the tour desk during
the hours noted above.
PRIVATE SOCIAL FUNCTIONS POLICY
DIA does not allow any hospitality functions to be held during any DIA 2012
offerings, scheduled exhibit hours, or social events. Therefore the hours
noted below are the only hours acceptable for hospitality functions:
Saturday, June 23
Sunday, June 24
Monday, June 25
Tuesday, June 26
Wednesday, June 27
Thursday, June 28
All times are acceptable
All times are acceptable
Before 8:00 AM and after 6:30 PM
WiFi
Complimentary wireless is available in the meeting room concourses. Follow
the following instructions to connect:
SELECTION OF OFFERINGS
1.
Please note that seating for offerings is on a first-come, first-served basis.
Attendees should be prepared with an alternate selection in the event that
a room is filled to capacity.
Configure your laptop or notebook computer’s network settings
to use DHCP (Default for MS Windows-based computers)
2.
Connect to the SSID: PACONVENTION
No password is required
3.
Launch your Internet browser
Selected program offerings will be recorded and audio synchronized
presentations will be available 2 weeks via DIA’s Live Learning Center.
See page 18 for more information.
Complimentary wireless is not provided inside the meeting rooms or in the
exhibit hall. However there is a WiFi area, located in the back of Exhibit Hall C,
supported by:
19
CONTINUING EDUCATION
The DIA 2012 is the premier event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology,
medical devices, and related products. In an effort to streamline the program and focus on the hottest topics, this year’s program will offer 20 preconference
programs and tutorials, 22 content-area tracks comprising approximately 280 program offerings, with presentations geared to attendees of all disciplines, work
settings, and experience levels.
LEARNING OBJECTIVES
At the conclusion of this meeting, participants
should be able to:
TRACK 1: CLINICAL OPERATIONS
đƫ Recognize the current clinical trial challenges
of costs, global execution and management by
using innovative technologies and practices
đƫ Ensure ethical and safe treatment of subjects in
the modern global trial arena
TRACK 2: PROJECT/PORTFOLIO MANAGEMENT
AND STRATEGIC PLANNING
đƫ Identify project management and finance
current trends, practices, and systems used
in global product development, including
strategic planning
đƫ Discuss portfolio asset strategy decision
making, management, portfolio/product
prioritization and optimization practices,
including relevant methods and tools
đƫ Describe quality design of clinical trials,
complexity of study development, and building
quality risk management into clinical trials
TRACK 3: INNOVATIVE PARTNERING MODELS
AND OUTSOURCING STRATEGIES
đƫ Discuss innovative partnering models and
unique outsourcing strategies that are
shaping the way in which pharmaceutical and
biotechnology companies work with Contract
Research Organizations (CROs) and other
service providers, academia, co-development
partners, and other organizations
TRACK 4: NONCLINICAL AND TRANSLATIONAL
DEVELOPMENT/EARLY PHASE CLINICAL
DEVELOPMENT
đƫ Explain some of the latest nonclinical and
clinical technologies and approaches for
assessing the safety of pharmaceutical
products
đƫ Discuss recent advances in coping with
particularly challenging regulatory and
scientific issues that arise in the early phases of
novel pharmaceutical development
đƫ List current strategies for designing successful
early clinical pharmacology and experimental
medicine trials
TRACK 5: PRODUCT ADVERTISING AND
MARKETING
đƫ Discuss the current regulatory landscape
related to drug advertising and promotion
TRACK 6: MEDICAL WRITING AND MEDICAL
COMMUNICATIONS
đƫ Identify opportunities to collaborate and meet
the expectations of multiple, global regulatory
authorities, patients, payers, and other
customers
TRACK 7: PROCESSES AND TECHNOLOGIES FOR
CLINICAL RESEARCH
đƫ Describe how technologies and processes are
used in clinical trials
đƫ Discuss how both technical and procedural
innovations, including forward-thinking
validation and qualification approaches, may
transform the clinical trial life cycle in the
future
TRACK 8: REGULATORY AFFAIRS AND
SUBMISSIONS
đƫ Discuss the latest global regulatory trends and
developments that impact the industry
đƫ Recognize key issues associated with evolving
regulatory standards
TRACK 9: MEDICAL DIAGNOSTICS AND DEVICES
đƫ Identify opportunities for drug companies to
address changing regulations in the area of
medical devices, diagnostics, and drug/device
combination products
TRACK 10: PUBLIC POLICY/HEALTH CARE
COMPLIANCE REGULATORY LAW
đƫ Discuss implications and recommendations
raised in health care compliance, public policy
and regulatory law
TRACK 11: COMPLIANCE TO GOOD CLINICAL
PRACTICE (GCP), GOOD LABORATORY
PRACTICE (GLP), AND QUALITY ASSURANCE
(QA)
đƫ Describe how to avoid GCP/GLP
noncompliance through innovation and
collaboration in a period of increasing
complexity and globalization in clinical trials
TRACK 12: PHARMACEUTICAL QUALITY
đƫ Explain how to apply fundamental and
advanced scientific and regulatory approaches
to current and emerging pharmaceutical
quality issues, including a strong emphasis
on global harmonization efforts within and
outside ICH
TRACK 13: HEALTH ECONOMICS AND
OUTCOMES (HEO)/ COMPARATIVE
EFFECTIVENESS RESEARCH (CER)/HEALTH
TECHNOLOGY ASSESSMENT (HTA)
đƫ Build the scientific capability to measure and
communicate the medical need, health impact,
and economic value associated with medical
products
đƫ Describe the real-world use of
Pharmacoeconomics & Outcomes Research
(PEOR), Health Technology Assessments,
Comparative Effectiveness, and Registries
TRACK 14: CLINICAL SAFETY AND
PHARMACOVIGILANCE
đƫ Discuss a broad array of concepts and tools
(traditional and new) that support participants’
pursuit of excellence in patient safety, for both
investigational and marketed products
TRACK 15: STATISTICAL SCIENCE AND
QUANTITATIVE THINKING
đƫ Identify innovative statistical solutions to issues
associated with the evidence and regulatory
review of drugs, diagnostics/devices, and
biologics
đƫ Describe relevant application of statistical
science and quantitative thinking to the
development of new therapeutic biologics,
drugs, and diagnostics/devices
TRACK 16: PROFESSIONAL DEVELOPMENT
đƫ Discuss ways to foster collaborative innovation
through professional development and
educational efforts
20
TRACK 17: GLOBAL REGULATORY
đƫ Discuss key initiatives, changes, and challenges
of various global regulatory agencies with
the review of drugs, diagnostics/devices, and
biologics
TRACK 18: RARE/NEGLECTED DISEASES
đƫ Discuss key initiatives, development and
strategies involving rare diseases, special
populations and orphan drugs
TRACK 19: SIAC SHOWCASES
đƫ Discuss discipline-specific topics with a global
community and share common experiences
and knowledge with others in their particular
field
TRACK 20: EXECUTIVE PROGRAM—PIONEERING
PARTNERSHIPS
đƫ Discuss collaborative research with members
of the payer community
đƫ Identify challenges of precision medicine
associated with diagnostics, reimbursement
and partnership co-development
TRACK 21: LATE-BREAKER
đƫ Discuss the Physician Payment Act and its
likely impact on the public health and all
stakeholders
đƫ Explain the importance of the CDISC/C-Path
partnership toward developing therapeutic
area standards and the benefits
đƫ Recognize the readiness of EHRs to support
regulated research and the potential value of
EHRs for clinical research
Target Audience
This meeting is designed for individuals involved
in the discovery, development, and life cycle
management of pharmaceuticals, biotechnology,
medical devices, and related products. The
meeting is intended to strengthen professionals’
understanding of the value of cross-discipline
integration and to foster innovation for better
health outcomes.
Continuing Education
Select program offerings (including sessions,
forums, workshops, symposia) will offer AMA
PRA Category 1 Credits™, pharmacy or nursing
contact hours, or PMI professional development
units (PDUs) and will be clearly identified in the
program with the statement of CME, Pharmacy,
Nursing, and PMI PDUs. IACET continuing
education units (CEUs) are offered for ALL
program offerings.
Continuing education credits are not available for
the plenary session on Monday morning or for the
white paper presentations. Learning objectives for
each program offering will be shown as a slide in
the meeting rooms.
Continuing Education
ACCREDITATION & CREDIT DESIGNATION
STATEMENT OF CREDIT
Accreditation Council for Continuing Medical Education (ACCME)
This activity has been planned and implemented in
accordance with the Essential Areas and policies of
the Accreditation Council for Continuing Medical
Education (ACCME) through the joint sponsorship of Postgraduate Institute
for Medicine (PIM) and the Drug Information Association. PIM is accredited
by the ACCME to provide continuing medical education for physicians.
Participants who would like to receive continuing education credits for the
Annual Meeting must scan their DIA name badge at each program offering
to record their attendance and complete each program offering evaluation
form. Participants may scan their badges within 45 minutes after the start of
each program offering. Attendees who do not scan their badges within the
allotted time will not be eligible to request the available continuing education
credits for that program offering.
The Postgraduate Institute for Medicine designates this live activity for a
maximum of 19 AMA PRA Category 1 Credit(s)™. Physicians should claim only
the credit commensurate with the extent of their participation in the activity.
Accreditation Council for Pharmacy Education (ACPE)
The Drug Information Association is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants may earn up to 19 contact hours
or 1.9 continuing education units (CEUs) for participating in the Annual
Meeting program offerings.
To request a statement of credit, please go to www.diahome.org, select
“Login to My DIA” and you will be prompted for your user ID and password.
Select “My Transcript” (left side bar) and “Credit Request” for each program
offering. My Transcript will be available for all Annual Meeting participants to
request credit on Tuesday, July 3.
Keep in mind, to receive continuing education credit you must:
đƫ Scan your DIA name badge at each program offering
đƫ Complete an online evaluation form for each program offering you
attend
đƫ Request a statement of credit by visiting www.diahome.org
If you experience any difficulties, please contact DIA at
[email protected].
For a complete list of each ACPE UAN and activity type allocated for the
pharmacy-certified program offerings, please refer to pages 141–142.
American Nurses Credentialing Center (ANCC)
This educational activity for 19 contact hours is provided by PIM.
PIM is accredited as a provider of continuing nursing education
by the American Nurses Credentialing Center’s Commission on
Accreditation.
California Board of Registered Nursing
PIM is approved by the California Board of Registered Nursing, Provider
Number 13485 for 19 contact hours.
Project Management Institute (PMI)
The Drug Information Association has been reviewed and
approved as a provider of project management training by
the Project Management Institute (PMI). Participants may
receive up to 19 professional development units (PDUs) for attending the
Annual Meeting program offerings. PMI #: 2166-000142
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) and DIA assess conflicts of interest with instructors, planners, managers, and other individuals who are in
a position to control the content of CME activities. All relevant conflicts of
interest that are identified are thoroughly vetted by PIM and DIA for fair balance, scientific objectivity of studies utilized in this activity, and patient care
recommendations. PIM and DIA are committed to providing learners with
high quality CME activities and related materials that promote improvements
or quality in healthcare and not a specific proprietary business interest of a
commercial interest.
The faculty members', planners', and managers' financial relationships or
relationships to products or devices they or their spouse/life partner have
with commercial interests related to the content of this continuing education
activity are noted on pages 133–140.
The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc.
International Association for Continuing Education and Training (IACET)
Drug Information Association has been accredited as an
Authorized Provider by the International Association for
Continuing Education and Training (IACET), 1760 Old Meadow
Road, Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers
CEUs for its programs that qualify under the ANSI/IACET Standard. Drug
Information Association is authorized by IACET to offer up to 2.5 CEUs for
this program.
Continuing Legal Education
For attorneys who would like to receive continuing legal education credits
for attending DIA 2012 Annual Meeting please complete your state’s
application for credit and submit accordingly.
If you require additional information to complete your application, please
contact Karen Wetzel at [email protected] for assistance.
To Calculate Your Credits from the Annual Meeting Program Offerings
Monday, June 25 through Thursday, June 28, 2012
The majority of the program offerings which indicate they are designated
for credit offer up to:
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. PIM and DIA do
not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty
and do not necessarily represent the views of PIM or DIA. Please refer to the
official prescribing information for each product for discussion of approved
indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a
guideline for patient management. Any procedures, medications, or other
courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s
conditions and possible contraindications on dangers in use, review of any
applicable manufacturer’s product information, and comparison with recommendations of other authorities.
1.5 AMA PRA Category 1 Credit(s)™
1.5 pharmacy contact hours or (.15 CEUs)
1.5 nursing contact hours
1.5 PMI professional development units
.2 IACET CEUs
Evaluation
DIA 2012 Annual Meeting will continue its online evaluation process for all
program offerings again this year. In order to simplify the evaluation process,
all attendees’ badges will be scanned upon entry to all meeting rooms, up
to 45 minutes after the start for each program offering. This will enable DIA
to ensure that you receive evaluations for only those program offerings that
you attended. At the end of each day, you will receive an email notification
requesting your feedback on the program offerings you attended. If a participant attends multiple program offerings within the same time frame, the last
scanned entry will be recorded.
Please note: The program offering on Tuesday, June 26 beginning at 3:30 PM
offers up to 1 hour of the above-mentioned credits and/or .1 IACET CEU.
DIA Certificate Programs
Individuals enrolled in DIA Certificate Programs may receive elective units
for the designated programs noted below:
Clinical Research Certificate Program:
Certificate Program:
Project Management Certificate Program:
Regulatory Affairs Certificate Program:
14 Elective Units
4 Elective Units
8 Elective Units
14 Elective Units
To thank you for your feedback, DIA will conduct a drawing from attendees
who completed all program offering evaluations for each day of the meeting. The drawing winner (1) will receive a new iPad. The drawing will be
announced and the prize distributed the week of July 16, 2012.
For more information on DIA’s Certificate Program, visit www.diahome.org/
certificateprograms.
21
DIA 2012 ANNUAL MEETING SCHEDULE
DIA 2012 ANNUAL MEETING TRACKS
Track #
Track Title
Track 01
Clinical Operations
Track 02
Project/Portfolio Management and Strategic Planning
Project Management (PM), Financing (FI), Strategic Planning (SP)
Track 03
Innovative Partnering Models and Outsourcing Strategies
Outsourcing (OS)
Track 04
Nonclinical and Translational Development/Early Phase Clinical
Development
Biotechnology (BT), Nonclinical (NC), Pharmacology (PC)
Track 05
Product Advertising and Marketing
Advertising and Promotion (AP), Marketing (MA)
Track 06
Medical Writing and Medical Communications
Medical Writing (MW), Medical Communication (MC)
Track 07
Processes and Technologies for Clinical Research
Information Technology (IT), eClinical (EC), Clinical Data Management
(CDM), Study Endpoints (SE), Document Management (DM), Validation (VA)
Track 08
Regulatory Affairs and Submissions
Regulatory Affairs (RA), Submissions (SUBS)
Track 09
Medical Diagnostics and Devices
Combination Products (CmbP), Medical Devices and Diagnostics (MDD)
Track 10
Public Policy/HealthCare Compliance/Regulatory Law
Public Policy, Law, Corporate Compliance (PPLCC)
Track 11
Compliance to Good Clinical Practice (GCP), Good Laboratory
Practice (GLP), and Quality Assurance (QA)
Good Clinical Practices (GCP), Quality Assurance and Quality Control
(QA/QC)
Track 12
Pharmaceutical Quality
Chemistry, Manufacturing and Controls (CMC)
Track 13
Health Economics and Outcomes (HEO)/Comparative
Effectiveness Research (CER)/Health Technology Assessment
(HTA)
Comparative Effectiveness/Health Technology Assessment/Evidence-based
Medicine (CEHTAEbM), Pricing and Reimbursement (PR)
Track 14
Clinical Safety and Pharmacovigilance (CP)
Track 15
Statistical Science and Quantitative Thinking
Statistics (ST)
Track 16
Professional Development
Professional Education, Training & Development (PETD)
Track 17
Global Regulatory
Includes program offerings hosted by a specific Regulatory Agency such as
the FDA, US; SFDA, China; European Union; PMDA, Japan; Health Canada,
Canada; etc. See page 6 for more information.
Track 18
Rare/Neglected Diseases
Rare and Neglected Diseases (RND)
Track 19
SIAC (Special Interest Area Community) Showcase
ALL
Track 20
Executive Program: Pioneering Partnerships
See page 7 for additional details
Track 21
Late-breaker
ALL
Track 22
White Paper Showcase
ALL
Number
Related Interest Areas
Clinical Research (CR), Research and Development (RD) Investigative
Sites (IS), Manufacturing (MF)
Track
Number
Title of Offering
Type of
Format
Level of
Difficulty
Forum
LEVEL: ●
Interest Area(s)
Room
Number
SUNDAY, JUNE 243:00–5:00 PM
DIA 2012 Student Forum
125
MONDAY, JUNE 258:00–9:30 AM
Forum
Welcome Remarks, Keynote Presentation, and Award Presentations
All registrants are encouraged to attend.
Terrace
Ballroom
MONDAY, JUNE 2510:00–11:30 AM
#101
Investigator Site Relationship Management WORKSHOP*
Track 01A
Workshop*
LEVEL: ■
IS, CR, PM
121c
#102
EMRs for Clinical Research: Hype versus Reality - A Management Primer
Track 01B
Session
LEVEL: ◆
CR, CDM, EC
108a
#103
Clinical Supply Chain Symposium
Track 01C
Symposium
LEVEL: ■
CR, PM, MF
109ab
#104
Overcoming Organizational Resistance to Portfolio Management
Track 02A
Session
LEVEL: ■
PM, RD
105ab
#105
Data Quality by Design (DQbD) to Improve the Quality of Clinical Trial Data
in Multiregional Clinical Trials (MRCTs)
Track 02B
Session
LEVEL: ■
QAQC, CDM, CR
103c
#106
Best Practices in Managing Alliances: Using the Balanced Scorecard
Methodology to Align Strategy and Operational Execution
Track 03
Workshop*
LEVEL: ■
OS, SP, PM
123
*Due to their interactive format, Workshops will not be recorded.
22
DIA 2012 Meeting Schedule
● Basic-level content; ■ Primarily intermediate-level content; ◆ Primarily advanced-level content
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
Track 04
Session
LEVEL: ■
CP, NC, CR
124
MONDAY, JUNE 2510:0O–11:30 AM, continued
#107
First-in-human Challenges of Biologics and Biosimilars
#108
Advancing Benefit-risk Visualization and Communication
Track 06
Session
LEVEL: ◆
MW, RA, CP
108b
#109
New Ways to Learn What Happens to Patients AFTER Approval
Track 07
Session
LEVEL: ◆
CP, IT, CDM
103a
#110
Transforming Regulatory Information Into Actionable Regulatory
Intelligence for Emerging Markets
Track 08A
Forum
LEVEL: ■
RA, CR, PM
115c
#111
Effective Switching from Rx to OTC Status: Maximimizing Revenue and
Profit From Off-Patent Products
Track 08B
Forum
LEVEL: ■
RA, CR, PPLCC
119b
#112
Companion Diagnostics: Current and Future Developments
Track 09
Session
LEVEL: ■
RA, CR, RD
118c
#113
Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
Track 10
Workshop*
LEVEL: ●
CP, RA, IS
120bc
#114
Defining Quality in Clinical Trials
Track 11
Session
LEVEL: ■
CR, CP, QAQC
119a
#115
ICH Update on Pharmaceutical Quality
Track 12
Forum
LEVEL: ●
CMC, RA, MF
122b
#116
The Impact of Social Media on Product Promotion and Pharmacovigilance
Track 14A
Forum
LEVEL: ●
AP, RA, MC
121ab
#117
Approaches to Postapproval Pediatric Safety Surveillance
Track 14B
Session
LEVEL: ■
CP, CDM, EC
118a
#118
Hot Topics in Statistics: Industry, CRO, Academic, and Regulatory
Perspectives
Track 15
Forum
LEVEL: ■
ST, RA, OS, BT
113a
#119
Translational Medicine in Africa: Challenges and Opportunities for Product
Development
Track 16
Session
LEVEL: ■
CR, RD, CP
117
#120
European Town Hall: Part 1 of 2 – Hot Topics in Europe
Track 17A
Forum
LEVEL: ■
RA, CP, CR
113c
#121
Pediatric Drug Development Progress: 15 Years Later and Across the Globe
Track 17B
Forum
LEVEL: ■
RA, PPLCC, ST
116
#122
Drug Development Strategies for Integrating Academia, Non-governmental
Organizations (NGOs), and Industry Based on Experience in Neglected and
Infectious Diseases
Track 18
Session
LEVEL: ■
CR, RD, SP
111ab
#123
Standards for Patients: Collaborations to Innovate Therapy Development
Track 21
Session
LEVEL: ■
CP, CDM, EC, IT
103b
#124
The New Health Report 2012: Rethinking the Risk Equation in
Biopharmaceutical Development and Delivery
Track 22A
Session
LEVEL: ●
CP, PM, SP
125
#150
Free Agency is Here: Exploring Workforce Impact on Clinical Outsourcing
Track 22B
Session
LEVEL: ●
CR, RA, SP
113B
RD, IT
Exhibit
Hall
MONDAY, JUNE 2512:00–12:45 PM
Innovative Theater: Innovation in R&D and Commercialization through Big
Data Analytics
Special Session
#125
Increasing Protocol Complexity Places Challenges on Research Site
Budgeting
Track 01A
Session
LEVEL: ◆
CR, FI, PM
109ab
#126
Social Media: The Promise and Pitfalls for Patient Recruitment
Track 01B
Symposium
LEVEL: ■
AP, MA
108a
#127
Quality by Design in Clinical Development: Blessing or Burden?
Track 02A
Session
LEVEL: ■
RA, CR
103c
#128
Get the Team to Take Charge!
Track 02B
Workshop*
LEVEL: ■
PM, PETD
121c
#129
Managing a Complex Outsourcing Collaboration
Track 03
Session
LEVEL: ■
OS, PM, SP
105ab
#130
Renal Impairment Studies Design, Conduct, and Analysis
Track 04
Forum
LEVEL: ●
NC, CR, RA
124
#131
Wrangling the Bestiary of Safety Documents: Coordination and Integration
across Multiple Requirements
Track 06
Session
LEVEL: ■
MW, CP, RA
108b
#132
Capitalizing on Biometric Efficiencies: A Look at Data Start-up, Capture,
Monitoring, and Reporting
Track 07A
Session
LEVEL: ●
CDM, IT, EC
103b
#133
Implications of Mobile Health and Clinical Research
Track 07B
Forum
LEVEL: ■
CDM, CR, IT
103a
#134
Regulatory Roundtable on Biosimilars
Track 08A Forum
LEVEL: ■
RA, CR, RD
113c
#135
New Challenges from Outsourcing of Regulatory Operations
Track 08B
Session
LEVEL: ■
OS, RA
115a
#136
Regulatory Strategies to Accelerate Approval in Emerging Markets
Considering the Growing Complexity of Requirements and Supply Chains
Track 08C
Session
LEVEL: ■
RA, MF, PM
119b
#137
Challenges and Opportunities for Drug Development in China
Track 08D
Session
LEVEL: ■
CR, PM, RD
116
#138
Where is the 510(k) Today
Track 09
Session
LEVEL: ●
RA, PPLCC, CmbP
118c
23
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
MONDAY, JUNE 251:30–3:00 PM, continued
#139
Regulatory Collaboration/21st Century Innovation: Views of the Heads of
Health Canada, the European Medicines Agency, and the US FDA
Track 10
Session
LEVEL: ■
RA
120bc
#140
Quality by Design: Is Your Clinical Trial Fit for Purpose?
Track 11A
Session
LEVEL: ◆
GCP, CP, CDM
119a
#141
Good Laboratory Practice (GLP): Design and Inspection Readiness
Track 11B
Symposium
LEVEL: ●
RD, PETD, QAQC
115c
#142
Postapproval Change Pathways in EU and US: Challenges and
Opportunities for Harmonization
Track 12
Session
LEVEL: ■
PC, RA, CP
122b
#143
Demystifying Approaches to the Design and Analysis of Observational
Studies of Comparative Effectiveness
Track 13
Forum
LEVEL: ■
CP, CR
107ab
#144
AE Reporting in the Era of Web 2.0: The Challenges of Having a Two-Way
Conversation
Track 14A
Forum
LEVEL: ●
CR, MC, AP
121ab
#145
Epidemiologists in Industry and in CROs: Penultimate Generalists and
Utterly Indispensible Scientists
Track 14B
Session
LEVEL: ●
CR, PM, ST
118a
#146
Extrapolation to Estimate Treatment Effects in Subgroups of Special
Interest
Track 15
Forum
LEVEL: ■
CP, RA
113a
#147
My Big Break: Women At the Top in the Biotechnology Sector
Track 16
Forum
LEVEL: ●
CR, BT, RA
117
#148
European Town Hall: Part 2 of 2 - Interacting With the European System
#149
Challenges of Orphan Drugs in the US, EU, and Japan
Track 18
Session
#150
Free Agency is Here: Exploring Workforce Impact on Clinical Outsourcing
MOVED TO MONDAY, JUNE 25, 3:30–5:30 PM
LEVEL: ■
RA
111ab
MOVED TO MONDAY, JUNE 25, 10:00–11:30 AM
#148
European Town Hall: Part 2 of 2 - Interacting With the European System
Track 17
Forum
LEVEL: ■
RA, CP
120bc
#151
A Day in the Life of a Clinical Research Site: What’s Getting in the Way?
Track 01A
Forum
LEVEL: ■
CR, IS, PM
109ab
#152
ePatient Recruitment, Study Sites, and the Digital Divide
Track 01B
Forum
LEVEL: ■
CR, FI, EC
108a
#153
Enhancing Decision Making and Maximizing Portfolio Value Creation Using
a Novel Portfolio Management Framework
Track 02A
Workshop*
LEVEL: ■
PM, IT
121c
#154
Keys to Successful Project Execution: Innovative Approaches to Critical
Chain, Critical Path, and Risk Management
Track 02B
Session
LEVEL: ■
PM, CR, SP
103c
#155
Pharma R&D in Asia: Opportunities, Models, and Challenges
Track 03A
Symposium
LEVEL: ■
OS, RD, CR
111ab
#156
Pre-competitive Public Private Partnerships: The Changing Model of
Pharmaceutical R&D
Track 03B
Session
LEVEL: ■
OS, RD, RA
105ab
#157
Drug QT Derisking: Changes in When and How
Track 04
Session
LEVEL: ■
PC, NC, CP
124
#158
Communicating Drug Safety Information Using Social Media: FDA and
Industry Perspectives
Track 06
Session
LEVEL: ■
MC, CP, RA
108b
#159
PRO Measurement in Clinical Trials: Need for Education and Training
Track 07A
Session
LEVEL: ■
EC, SE, IT
103b
#160
Electronic Health Records (EHR)/Electronic Data Capture (EDC)
Opportunities
Track 07B
Session
LEVEL: ■
EC, IT, CDM
103a
#161
Analysis and Impact of PDUFA V: How the Changes Will Affect the Work
of Regulatory Affairs Professionals
Track 08A
Session
LEVEL: ■
RA, CR, PPLCC
113c
#162
Streamlining of Clinical Trial Review Process in Asian Pacific Region
Track 08B
Session
LEVEL: ■
RA, CR, PM
115a
#163
Vaccines: FDA and Japan Perspectives
Track 08C
Forum
LEVEL: ■
CR, RA, MC
119b
#164
Discussion with Former Center for Devices and Radiological Health (CDRH)
Management
Track 09
Session
LEVEL: ◆
RA
118c
#165
Legal Jeopardy from the Conduct of Clinical Trials
Track 10
Forum
LEVEL: ●
CR, IS
116
#166
Conducting Clinical Trials in Developing Countries: Challenges in Meeting
Good Clinical Practice (GCP) Compliance
Track 11A
Symposium
LEVEL: ■
RA, CR
119a
#167
Building Quality into Clinical Trials: Regulatory Perspectives and Practical
Considerations
Track 11B
Session
LEVEL: ■
CR, CP, QAQC
115c
#168
Opportunities for Global Harmonization of Inspection Paradigm
Track 12
Session
LEVEL: ■
CM, MF, RA
122b
#169
Application of Quality of Evidence Assessment Tools to the Evaluation of
Observational Pharmacoepidemiologic Studies
Track 13
Forum
LEVEL: ■
CP, CDM
107ab
#170
Electronic Health Records (EHR) and Medication Safety and Adherence
Track 14A
Symposium
LEVEL: ■
DM, CR, CDM
121ab
24
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
MONDAY, JUNE 253:30–5:00 PM, continued
#171
Use It Early and Often: Epidemiology’s Many Roles in Clinical Development
and Beyond
Track 14B
Session
LEVEL: ■
CR, RD, RA
118a
#172
Rates and Weights: Quantifying Clinical Impact and Judgment in
Benefit-risk Assessment
Track 15
Session
LEVEL: ■
CP, CR
113a
#173
Building International Competence in Drug Development Teams
Track 16
Symposium
LEVEL: ■
CR, RA, PM
117
#174
An Update on EMA, FDA, and PMDA International Activities
Track 17
Session
LEVEL: ●
RA, PPLCC
113b
#175
Raising the Bar for Regulatory Submission Document Quality:
A Collaborative, Transitional Approach
Track 22
Session
LEVEL: ●
RA, MW, DM
125
TUESDAY, JUNE 268:00–9:30 AM
#201
Optimizing Drug Development Portfolios: An Integrated Approach
Track 02A
Session
LEVEL: ■
PM, FI, SP
103c
#202
Project and Program Management Competency Models for the (Bio)
Pharmaceutical Industry
Track 02B
Session
LEVEL: ■
PM, SP
113b
#203
The New Reality - Strategic Partnerships under Scrutiny: Are They Working,
and How Long Will It Take to Ensure Success?
Track 03
Forum
LEVEL: ■
OS, SP, CR
105ab
#204
Novel Imaging Techniques Symposium
Track 04
Symposium
LEVEL: ■
BT, NC, PC
124
#205
Medical Contributions to Promotional Tactics
Track 06
Session
LEVEL: ■
MC, AP, CDM
108b
#206
Defining Study Endpoints in 2012: The Journey Continues
Track 07A
Session
LEVEL: ■
SE, RA, CEHTAEbM
103a
#207
Evolving eContent Design and Exchange for Clinical Studies
Track 07B
Symposium
LEVEL: ■
CDM, EC, IT
103b
#208
Meta-collaborations: A Call to Action
Track 08A Forum
LEVEL: ■
RA, CEHTAEbM, SP
Terrace 4
#209
Electronic Drug Registration and Listing: FDA and Industry
Track 08B
Session
LEVEL: ■
DM, SUBS, RA
120bc
#210
Legal Aspects of Clinical Trial Compliance
Track 10
Session
LEVEL: ◆
RA, CR
113c
#211
Quality Risk Management WORKSHOP*
Track 12
Workshop*
LEVEL: ●
QAQC
123
#212
Recent Advancement of HTA and Its Impact on Health Care Reform and
Product Life Cycle Management in the Asian Pacific Region
Track 13
Session
LEVEL: ■
CR, RA, RD
107ab
#213
Data Monitoring Committee (DMC): When You Need One and When You Don’t!
Track 14
Session
LEVEL: ■
GCP, CR, RA
121ab
#214
NDA/BLA Statistical Review and the CDISC ADaM Data Standards
Track 15
Forum
LEVEL: ■
CDM
113a
TUESDAY, JUNE 2610:00–11:30 AM
#215
Understanding Risk-based Monitoring: Is It Art, Science, or Both?
Track 01A
Symposium
LEVEL: ■
CP, EC, RA
108a
#216
The Next Patient Recruitment Frontier: Leveraging Mobile Health Care
Technology (mHealth) to Recruit Patients for Clinical Trials
Track 01B
Forum
LEVEL: ■
CR, IT, PM
111ab
#217
Update on Collaborative Projects of the Clinical Trials Transformation
Initiative (CTTI)
Track 01C
Session
LEVEL: ■
CP, IS
109ab
#218
Optimizing Performance in Outsourced Projects in China and Other Asian
Countries
Track 02A
Session
LEVEL: ●
OS, PM
113b
#219
Improving Protocol Design: Current Industry Practices and New
Approaches
Track 02B
Session
LEVEL: ■
FI, PM, CR
103c
#220
The Unintended Consequences of Strategic Partnerships
Track 03
Session
LEVEL: ●
OS, SP, CR
105ab
#221
Skin-drug Biotransformation: What Testing Should We Do?
Track 04
Session
LEVEL: ◆
NC, CP, PC
124
#222
Publish or Perish: Retracted Scientific Literature
Track 06
Forum
LEVEL: ■
MC
108b
#223
Labeling Claims Based on Patient-reported Outcome Measures: It Takes a
Village!
Track 07A
Forum
LEVEL: ●
EC, SE, CDM
103a
#224
Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery
and Reinvestment Act Patient Centered Outcomes Research) Data
Standardization Efforts
Track 07B
Session
LEVEL: ■
CDM, IT, RA
103b
#225
Pediatric Development in the US: Implementation of 2007 PREA and BPCA
Against a Backdrop of the EU Pediatric Legislation
Track 08A
Session
LEVEL: ■
CR, PPLCC
119b
#226
Drug Shortages 2012: Rewind, Repeat, Recovery
Track 08B
Session
LEVEL: ■
RA, CP, MF
120bc
#227
Combination Products
Track 09
Symposium
LEVEL: ●
CmbP, RA
118c
25
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
TUESDAY, JUNE 2610:00–11:30 AM, continued
#228
Product Liability in the US and the EU
Track 10
Session
LEVEL: ●
CP, RA
113c
#229
Misconduct and Management of Serious or Continued Noncompliance:
What Are the Differences and Similarities?
Track 11
Session
LEVEL: ◆
RA, CR, IS
115c
#230
Preparing for CMC Meetings with the FDA
Track 12
Session
LEVEL: ●
CMC, RA, CR
119a
#231
The Effects of NICE Technology Assessments on Prescribing and Costsharing Behavior in the US
Track 13
Session
LEVEL: ●
PR, CR, RA
107ab
#232
Comparison of National-level Drug Utilization Patterns from Large
Commercial Health Care Databases with Mini-Sentinel
Track 14A
Session
LEVEL: ■
CR, CDM, EC
121ab
#233
Pharmacovigilance in Japan and Risk Management Plans
Track 14B
Symposium
LEVEL: ■
CR, RA
118a
#234
FDA Draft Guidance on Multiple Endpoints in Clinical Trials
Track 15
Session
LEVEL: ■
CR, RA
113a
#235
Advanced Presentation Skills
Track 16A
Workshop*
LEVEL: ■
PETD
121c
#236
Introduction to Narrative Medicine
Track 16B
Workshop*
LEVEL: ●
CR, RD, CP
123
#237
International Regulatory Cooperation: A Canadian Perspective
Track 17A
Forum
LEVEL: ■
RA, CR, PM
116
#238
Track 17B
Forum
LEVEL: ●
CR, RA
117
#239
Value of Actigraphy in Clinical Trials
Track 22
Session
LEVEL: ●
CR, RA, CDM
125
Special Session
LEVEL: ●
ST, CR
Exhibit
Hall
TUESDAY, JUNE 2612:00–12:45 PM
Innovative Theater ADDPLAN PE- Innovative Software for Population
Enrichment Designs in Adaptive Clinical Trials
#240
Effective and Efficient Monitoring as a Component of Quality Assurance in
the Conduct of Clinical Trials
Track 01A
Forum
LEVEL: ■
CR, IS, QAQC
109ab
#241
Investigator Budgets’ Impact on Patient Enrollment and Retention: How to
Improve Sponsor/CRO/Site Selection Processes
Track 01B
Session
LEVEL: ■
CR, PR, RD
108a
#242
Sponsors and CROs: Don’t Be Misled By Your Site Performance Data
Track 01C
Workshop*
LEVEL: ■
CR, IS, CDM
123
#243
Planning Your Drug’s Development Life Cycle
Track 02A
Symposium
LEVEL: ■
PM, RD, CR
113b
#244
Leaping the Valley of Death: Keys to Successfully Going from the Lab to
the Clinic for Pharmaceutical Products
Track 02B
Session
LEVEL: ■
PM, SP, CR
103c
#245
Collaborative Partnerships in Drug Development: An Executive Roundtable
Discussion
Track 03
Forum
LEVEL: ◆
OS, CR, SP
121ab
#246
Product Candidate to Proof-of-concept: An Integrated Approach to
Accelerate Programs
Track 04
Session
LEVEL: ■
NC, PC, CP
124
#247
From Design to Disclosure: Pleasing Multiple Masters
Track 06
Symposium
LEVEL: ■
MW, CR, RA
108b
#248
Implementing Adaptive Clinical Trials: A Practical Perspective
Track 07A
Session
LEVEL: ■
CDM, EC, ST
103a
#249
Innovative Ways of Looking at Computer System Validation
Track 07B
Forum
LEVEL: ■
VA, IT, QAQC
103b
#250
An Ocean Apart? Integrating Distinct Health Authority Philosophies on
Personalized Medicines and Companion Assays
Track 08
Session
LEVEL: ■
PR, CmbP, MDD
120bc
#251
Funding Innovation and Creating Opportunities in the Device, Diagnostic,
and Drug Interface
Track 09
Session
LEVEL: ■
FI, RD
118c
#252
Drug Rediscovery as an Innovative Tool to Meet Unmet Medical Needs
Track 10
Session
LEVEL: ●
RA, RD
113c
#253
What Should You Put in a Clinical Quality Assurance (CQA) Agreement
Track 11
Session
LEVEL: ■
CR, CDM, QAQC
115c
#254
Practical Implementation of Knowledge Management
Track 12
Session
LEVEL: ■
CMC, RA, IT
119a
#255
Registries for Evaluating Patient Outcomes: Emerging Areas of
Controversy
Track 13
Forum
LEVEL: ●
CR, RD, RA
107ab
#256
Noninterventional Minimal Risk Research: A 360° Perspective
Track 14A
Session
LEVEL: ■
IS, RA
119b
#257
Stepping Up and Doing It Step by Step: Lessons Learned from Initial
Endeavors Exploring Health Care Data for Signal Detection
Track 14B
Session
LEVEL: ■
CDM, CR, EC
118a
#258
Noninferiority Trial Designs: Perspectives from Academia, Industry, and a
Regulatory Agency
Track 15
Session
LEVEL: ■
CR, RA
113a
26
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
TUESDAY, JUNE 261:30–3:00 PM, continued
#259
Definition and Validation of Core Competencies to Enhance the Quality of
Clinical Trials and Those Who Conduct Them
Track 16
Workshop*
LEVEL: ■
CR, IS, PETD
121c
#260
Update from the EMA-FDA Parallel Assessment Pilot
Track 17A
Session
LEVEL: ●
CMC, RA
122b
#261
SFDA Town Hall
Track 17B
Forum
LEVEL: ●
CMC, CR, RA
117
#262
Understanding the Challenges of Conducting Studies for Orphan
Indications and Rare Diseases
Track 18
Session
LEVEL: ■
PM, RD
111ab
#263
A Challenge for the Industry: What Will it Take for a Sponsor to Use EHRs
With a Regulated Research Protocol?
Track 21
Forum
LEVEL: ●
CR, IT, RA
105ab
#264
The Unique Relationship Between Global Patient Recruitment and
Translation Management
Track 22
Session
LEVEL: ●
CR, RA, MW
125
#265
Beyond Taxonomy
Track 19A
SIAC
LEVEL: ■
SE, CDM, EC
103a
#266
Breaking News Update: Cutting Edge Statistical Methods in Clinical
Development
Track 19B
SIAC
LEVEL: ■
ST, CR, RA
103b
#267
CDER Electronic Submissions Standards Update
Track 19C
SIAC
LEVEL: ●
SUBS, DM, CDM
121ab
#268
Controversial Guidance, eSource, and Standards: How Does It All Fit
Together in an eClinical World?
Track 19D
SIAC
LEVEL: ■
EC, CDM, RA
103c
#269
Cross-sector Innovation Brings Tailored Therapies to Patients
Track 19E
SIAC
LEVEL: ●
CR, BT, SP
108a
#270
Electronic Data Capture (EDC): How Much Quality is Enough?
Track 19F
SIAC
LEVEL: ■
CDM, EC, SE
105ab
#271
Emerging Professionals: Optimize your Transition into the Pharmaceutical Arena
Track 19G
SIAC
LEVEL: ●
PETD, CR, RA
107ab
#272
Evidence for the Marketplace: Bridging the Gap Between Industry, Payer,
Providers, and Patients
Track 19H
SIAC
LEVEL: ■
CEHTAEbM, PR, CR
108b
#273
Reference Models and the Framework for the Destruction of Paper: How
They Are Changing Our Industry
Track 19I
SIAC
LEVEL: ■
DM, RA, SUBS
109ab
#274
Globalization of Phase 1: Trends and Challenges
Track 19J
SIAC
LEVEL: ■
CP, PC, CR
111ab
#275
Good Pharmacovigilance Practice in a Global Environment
Track 19K
SIAC
LEVEL: ■
CP, RA, CR
113a
#276
Hot Topics in Clinical Trial Disclosure (CTD)
Track 19L
SIAC
LEVEL: ■
MW, CR, QAQC
113b
#277
Hot Topics in Regulatory Affairs Forum
Track 19M
SIAC
LEVEL: ■
RA, CR, PM
120bc
#278
How Medical Writers Are Improving Global Practice and Collaboration
Track 19N
SIAC
LEVEL: ■
MW, MC, RA
113c
#279
Leveraging Technology in an Age of Readily Available Information
Track 19O
SIAC
LEVEL: ■
MC, IT, AP
116
#280
Meet the Regulators: Helping You Ensure GCP Compliance by Knowing the
Most Frequent and Serious Findings
Track 19P
SIAC
LEVEL: ■
QAQC, GCP, RA
115c
#281
Navigating the Intersection of Outsourcing and Quality Oversight
Track 19Q
SIAC
LEVEL: ■
OS, PM, QAQC
117
#282
New Guidances on Quality Risk Management by FDA and EMA:
Implications for Industry
Track 19R
SIAC
LEVEL: ■
CR, RA, CP
118a
#283
Pediatric Clinical Trials: Modeling and Simulation to Support the Bridging
of Data
#284
The Future of Project Management in the Pharmaceutical Industry: What
Competencies Will Be Critical?
Track 19T
#285
Re-energize Your Career!
Track 19U
#286
Rx: A New World in Natural Health Products (NHP)
Track 19V
#287
Status of the Use of Electronic Health Records (EHR) in Clinical Research
#288
Who Owns the Service? Challenges in Collaboration Between IT and the
Business
CANCELLED
LEVEL: ■
PM, CR, RA
SIAC
LEVEL: ●
PETD, RA, CR
119b
SIAC
LEVEL: ■
CR, RD, RA
121c
Track 19W SIAC
LEVEL: ■
CDM, CR, VA
125
Track 19X
LEVEL: ■
IT, SP, ST
124
ST
120a
SIAC
SIAC
119a
TUESDAY, JUNE 264:30- 6:00 PM
Open Business Meeting for the Adaptive Design Scientific Working Group
27
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
WEDNESDAY, JUNE 278:00–9:30 AM
#301
How Industry Can Partner with FDA in Defining a Risk-based Monitoring
Program
Track 01A
Session
LEVEL: ■
CR, RA, CP
108a
#302
Collaboration and Globalization of Clinical Trials: What Does It Mean to
Pharmaceutical Project Managers?
Track 01B
Forum
LEVEL: ■
PM, CR, IT
109ab
#303
Integrating Pharmacogenomics and Companion Diagnostic Development
into the Integrated Clinical Development Plan
Track 02A
Session
LEVEL: ■
CR, PM, MC
105ab
#304
Asian Regulatory Agencies Relocated into Biotech Science Park as a
Strategy for Global Drug Development
Track 02B
Session
LEVEL: ■
RA, SP, PM
103c
#305
Risk-sharing Partnerships: Models for Managing Risk across the Clinicalcommercial Continuum
Track 03A
Forum
LEVEL: ■
OS, SP, FI
108b
#306
Patient Advocacy and Your Next Generation of Research: How Nonprofit
Organizations Can Accelerate Product Development
Track 03B
Session
LEVEL: ●
OS, CR, SP
111ab
#307
Nanotechnology: Regulatory Challenges and Opportunities
Track 04
Session
LEVEL: ●
BT, PC, NC
124
#308
Prescription Drug Marketing Regulatory Primer
Track 05
Workshop*
LEVEL: ●
RA, CP, MC
113b
#309
Implementing Structured Authoring: Understanding the DITA Model and Its
Applicability for Content and Metadata Management
Track 06
Workshop*
LEVEL: ●
MW, CMC, DM
121c
#310
Combining Patient Self-report and Clinician Oversight: Are Two Heads
Better than One?
Track 07A
Session
LEVEL: ■
CDM, EC, SE
103a
#311
eClinical Interoperability: Imagination, Integration, Implementation
Track 07B
Session
LEVEL: ■
EC, CDM, IT
103b
#312
Patient Advocacy in Medical Product Development: The Evolving
Relationship Between FDA and Its Patient Stakeholders
Track 08A
Session
LEVEL: ●
RA, CR, CP
119a
#313
Future Directions for eCTD Module 1
Track 08B
Session
LEVEL: ●
DM, SUBS, RA
120bc
#314
Clinical Trial Disclosures: A US and EU Regulatory Update
Track 08C
Session
LEVEL: ■
RA, CR, MW
119b
#315
Oncology Medications: State-of-the-art Identification and Management of
Potential CV Safety Issues During Development
Track 09
Session
LEVEL: ●
CP
118c
#316
Policy and Enforcement Trends: Are Regulators and Industry Heading in
the Right Direction?
Track 10
Forum
LEVEL: ■
RA
113c
#317
FDA and European Medicines Agency Collaboration: GCP Inspections and
Beyond
Track 11
Session
LEVEL: ■
GCP, RA, QAQC
121ab
#318
Auditing Pharmaceutical Quality Systems
Track 12
Session
LEVEL: ■
CMC, MF
122b
#319
Environment for Health Care Decision Making: The Role of CER, Evidencebased Medicine, Quality, and Value
Track 13
Session
LEVEL: ■
PR
107ab
#320
How to Be Prepared for Shifting Regulations on Combination Products
Track 14A
Session
LEVEL: ■
CmbP, RA, CR
115c
#321
Active Surveillance Using Large, Electronic Health Care Data Networks
Track 14B
Session
LEVEL: ■
EC, CDM, ST
118a
#322
Statistical Methods for Analysis of Integrated Safety Data
Track 15
Session
LEVEL: ■
CEHTAEbM, CR, CDM
113a
#323
Emerging Needs in Clinical Research and Drug Development Sciences
Education and Certification
Track 16
Session
LEVEL: ■
CR, PM, PETD
117
#324
Track 17
Forum
LEVEL: ■
RA, MF, CP
115a
#325
Enabling Remote Monitoring in Clinical Trials for Sponsors and Sites
Track 22
Session
LEVEL: ●
CR, RA, PM
125
WEDNESDAY, JUNE 2710:00–11:30 AM
#326
Clinical Research in Emerging Regions Around the World
Track 01A
Symposium
LEVEL: ■
CR, PM, SP
109ab
#327
Applying Longstanding Ethical Principles in a Period of Dynamic Change
Track 01B
Symposium
LEVEL: ■
PM, IT
108a
#328
Achieving Alignment in a Difficult and Diverse Environment
Track 02A
Forum
LEVEL: ●
MC, PETD, PM
105ab
#329
Project Risk Management Simulation for Product Development
Track 02B
Workshop*
LEVEL: ■
CP, CR
121c
#330
Partnering for Impact in Global Health
Track 03
Forum
LEVEL: ●
RA, SP, PM
121ab
#331
Can Human Carcinogenic Risk Be Communicated Without a Rodent
Bioassay?
Track 04
Forum
LEVEL: ◆
BT, PC
124
#332
FDA Enforcement Update: Advertising and Promotion
Track 05
Session
LEVEL: ■
RA, MC
113b
28
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
WEDNESDAY, JUNE 2710:00–11:30 AM, continued
#333
Efficient Regulatory Medical Writing for Global Submissions Including “ICH
Outlier” Authorities
Track 06
Session
LEVEL: ◆
MW, DM, RA
108b
#334
Identity Management Technologies in Clinical Trials
Track 07A
Session
LEVEL: ■
IT, CR, QAQC
103b
#335
Clinical Outcome Assessments in the Evaluation of Medical Products in
Pediatrics
Track 07B
Session
LEVEL: ■
EC, CR, CDM
103a
#336
Building the Benefit-risk Toolbox: Is There a Consensus on a Scientifically
Acceptable Framework?
Track 08A
Session
LEVEL: ■
RA, CP
119a
#337
Global Product Development: Resolving Conflicting Scientific and
Regulatory Advice from Multiple Health Authorities
Track 08B
Session
LEVEL: ■
RA, CR
119b
#338
Pursuing Standards to Enhance eCTD Deliverables: PhRMA Electronic
Regulatory Submissions (ERS) Group Annual Update
Track 08C
Forum
LEVEL: ■
DM, SUBS, RA
120bc
#339
Current Advancement of Regulatory Reform for Medical Devices in Asia
Pacific and Its Strategic Impact
Track 09
Symposium
LEVEL: ●
RA, CR
118c
#340
Meeting the Therapeutic Needs of Older Patients: A Sustainable
Collaborative Approach
Track 10
Session
LEVEL: ■
RA, CR
113c
#341
Regulatory Updates on Current Trends in Drug Quality and Manufacturing
Track 12
Forum
LEVEL: ■
CMC, MF, RA
122b
#342
REMS: Are Our Written Communications Truly Mitigating Risks to Patients?
Track 14A
Session
LEVEL: ■
CR, RA, RD
115c
#343
The Out-Sourcing/In-Sourcing/Out-Sourcing Model for Pharmacovigilance
Track 14B
Symposium
LEVEL: ●
OS
118a
#344
From Adverse Events to Adverse Drug Reactions: Statistical Issues in
Safety Labeling
Track 15
Session
LEVEL: ■
CP, DM, MW
113a
#345
Employee Engagement
Track 16
Symposium
LEVEL: ●
CR, RA, PM
117
#346
Natural History Studies for Rare Diseases and Orphan Conditions
Track 18
Session
LEVEL: ■
CR, RD, RA
111ab
WEDNESDAY, JUNE 271:30–3:00 PM
#347
Clinical, Statistical, and Data Management Considerations for Developing
Clinical Trial Protocols
Track 01A
Session
LEVEL: ■
CR, ST, CDM
109ab
#348
New Regulations and Guidance for Clinical Trials and Human Subject
Protection
Track 01B
Session
LEVEL: ■
CR, RA
108a
#349
Building Clinical Site Capacity for Research
Track 01C
Session
LEVEL: ■
CR, PM, SP
105ab
#350
Drug Development Strategies and Incorporation of an Established Project
Management System
Track 02
Session
LEVEL: ■
PM, OS, SP
103c
#351
Thinking Small! A Virtual Pharma Gets Big Work Done with Like-minded
Partners
Track 03A
Session
LEVEL: ●
SP, OS, CR
111ab
#352
Functional Service Provider Symposium
Track 03B
Symposium
LEVEL: ■
OS, FI, CR
118a
#353
Microdosing: Past Experience and Future Role in Translational Medicine
Track 04
Session
LEVEL: ■
PC, NC, CDM
124
#354
International Advertising/Promotion Coordination
Track 05
Session
LEVEL: ■
MC, MA
113b
#355
Global Medical Information in Real-life Situations
Track 06A
Session
LEVEL: ■
MC, DM, OS
108b
#356
What Medical Writers Need to Know about MedDRA
Track 06B
Workshop*
LEVEL: ■
CP, CDM
121c
#357
Innovations Aimed at Improving Effectiveness and Speed of the
Therapeutic Development Process
Track 07A
Session
LEVEL: ●
IT, CDM, MC
103a
Forum
#358
Business Applications in the Cloud
Track 07B
LEVEL: ■
CDM, IT, VA
103b
#359
Orphan Drug Development: Global Regulatory Challenges and Initiatives
Track 08A Session
LEVEL: ■
RA, CR, PM
120bc
#360
Operationalizing SDTM
Track 08B
Session
LEVEL: ●
DM, SUBS, RA
119b
#361
Update on Revision of European Medical Device Directives and Impact on
Industry
Track 09
Symposium
LEVEL: ■
RA, PPLCC
118c
#362
Emerging Development and Policy Trends in the Economics of the
Biopharmaceutical Industry
Track 10
Session
LEVEL: ●
RD, BT
113c
#363
The Changing Face of Clinical Compliance: Regulatory, Technology, and
Services
Track 11
Symposium
LEVEL: ■
GCP, CR, EC
121ab
#364
Quality Risk Management WORKSHOP*
Track 12
Workshop*
LEVEL: ●
CM, MF, CP
123
29
Number
Title of Offering
Track
Number
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
WEDNESDAY, JUNE 271:30–3:00 PM, continued
#365
The Use of Health Technology Assessment (HTA) for Access and Resource
Allocation Decision Making: International Examples
Track 13
Symposium
LEVEL: ■
PR, RA, PPLCC
107ab
#366
Data Sources for Monitoring Usage of Drug Products and How to Use
These Sources to Support Safety and REMS Evaluations
Track 14
Forum
LEVEL: ●
CDM, RA, CR
115c
#367
Impact of Bayesian Methods in Medical Product Development
Track 15
Session
LEVEL: ■
CP
113a
#368
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
Track 17A
Session
LEVEL: ■
RA, CR, RD
122b
#369
CBER Town Hall
Track 17B
Forum
LEVEL: ●
RA, CR
119a
#370
Social Media 2.0: The Power of Online Rare Disease Communities to
Connect and Engage ePatients
Track 18
Forum
LEVEL: ■
AP, CR
115a
#371
Implementation of Adaptive Clinical Trials
Track 22
Session
ST, CR, EC
125
WEDNESDAY, JUNE 273:30–5:00 PM
#372
Standard of Care: Challenges for Sponsors, Sites, and Patients in Clinical
Trial Budgets
Track 01A
Session
LEVEL: ■
IS, PR, PPLCC
109ab
#373
Special Populations Symposium
Track 01B
Symposium
LEVEL: ●
CR, PM, IS
105ab
#374
Optimizing Study Monitoring Performance and Efficiency
Track 01C
Symposium
LEVEL: ■
CR, PM, CDM
108a
#375
Planning and Execution of a Global Oncology Program
Track 02
Session
LEVEL: ■
PM, RA, CR
103c
#376
Effectively Managing Global Trials Within a CRO Alliance Structure
Track 03A
Forum
LEVEL: ■
OS, PM, CR
111ab
#377
Sites, CROs, and Sponsor Relationship Obstacles and Opportunities
Track 03B
Symposium
LEVEL: ■
CR, IS, OS
118a
#378
Biomarker Focused Strategies for Personalized Medicine
Track 04
Session
LEVEL: ●
NC, BT
124
#379
Leveraging Drug Development and Advertising/Promotion Regulatory
Expertise to Drive a Robust Target Product Profile Process
Track 05
Session
LEVEL: ■
RA, MC, CP
113b
#380
Recent Advances in Adaptive Clinical Trial Designs for Medical Writers
Track 06
Session
LEVEL: ■
MW, RA, ST
108b
#381
Sharing Clinical Data: Examples of What to Share and Benefits to Research
and Patients
Track 07A
Session
LEVEL: ■
IT, CDM, RD
103a
#382
Automation Through CDISC Standard Models: eProtocol, Data Submission,
and Safety Reporting
Track 07B
Symposium
LEVEL: ■
CDM, EC, SUBS
103b
#383
Adaptive Licensing: Bane or Boon for Drug Development?
Track 08A
Session
LEVEL: ■
RA, CR, ST
119b
#384
Update on Biosimilar Developments in the US
Track 08B
Session
LEVEL: ◆
RA, CR, PPLCC
120bc
#385
Emerging Role of the Patient Voice on Drug Policy in Japan
Track 10A
Session
LEVEL: ●
PPLCC, CP, RA
118c
#386
Regulatory Capacity Building from 360 Degrees
Track 10B
Forum
LEVEL: ■
CP
113c
#387
Good Clinical Practices (GCPs) through Good Documentation Practices
(GDPs)
Track 11
Workshop*
LEVEL: ■
GCP, CR, CDM
121c
#388
The Role of Meta-analyses in Drug Safety: Methodological Considerations
Track 13A
Forum
LEVEL: ■
CP, CR
107ab
#389
Benefit Versus Risk of Harm: Assessing Therapeutic Response and
Interpreting Benefit/Risk with Patients
Track 13B
Session
LEVEL: ■
CP
125
#390
Doping Abuse of Medicines in Sport: The Challenge to Industry and
Regulators
Track 14
Session
LEVEL: ■
CR, RD, PPLCC
115c
#391
Statistical Comparative Effectiveness Research (CER): Closing the Gaps in
the Consideration of Observational Evidence
Track 15
Session
LEVEL: ■
CEHTAEbM
113a
#392
Learning Through Knowledge Sharing and Virtual Worlds
Track 16A
Symposium
LEVEL: ●
CR, PM, PETD
117
#393
DIA 2013: Helpful Hints in Submitting an Abstract
Track 16B
Workshop*
LEVEL: ●
ALL
123
#394
The State of Electronic Submissions at CDER, CBER, and CDRH
Track 17A
Session
LEVEL: ●
SUBS, RA, IT
121ab
#395
India Town Hall
Track 17B
Forum
LEVEL: ■
RA
119a
#396
Rare Disease Clinical Research Consortia: Immediate and Rich Sources of
Translational Research Data, Partnering Opportunities
Track 18
Session
LEVEL: ●
CR, RD
115a
#397
Implementation of the Physician Payment Sunshine Act: Now What?
Track 21
Forum
LEVEL: ■
CR, PM, RA, PPLCC, QC
122b
#398
Accelerating Cancer Clinical Trials
Track 22
Session
LEVEL: ●
CR, RD
125
30
Number
Track
Number
Title of Offering
Type of
Format
Level of
Difficulty
Interest Area(s)
Room
Number
THURSDAY, JUNE 289:00–10:30 AM
#401
Clinical Trial Metrics Symposium
Track 01
Symposium
LEVEL: ■
CR, FI, CDM
113c
#402
Managing Drug Development Portfolios in a Safety-heightened
Environment
Track 02
Session
LEVEL: ◆
PM, CP, CDM
105ab
#403
Integrated Partnership: A Vaccine Case Study
Track 03A
Forum
LEVEL: ■
OS, SP, CR
111ab
#404
Multistakeholder Development Partnerships: Harnessing Differing
Perspectives, Objectives, and Strengths for Success
Track 03B
Symposium
LEVEL: ■
OS, SP, CR
109ab
#405
Hot Topics Symposium
Track 04
Symposium
LEVEL: ■
BT, RA, NC
124
#406
Study Recruitment Challenges, Tailored Medical Information Requests - OH
MY! Have You Maximized All Your Options
Track 06
Session
LEVEL: ■
MC, CR, CP
108b
#407
Cloud Computing in Regulated Environments
Track 07A
Workshop*
LEVEL: ■
IT, VA, CP
121c
#408
The Cross-over Between Direct-to-patient Studies, Social Media, and EDC
Track 07B
Session
LEVEL: ■
EC, IT, SE
107ab
#409
The Role of Corrective and Preventive Action (CAPA) in GCP/GLP Audit
Quality Management Systems
Track 11
Symposium
LEVEL: ■
GCP, CR, RA
121ab
#410
Coding with Confidence
Track 14
Workshop*
LEVEL: ■
CDM, CP, DM
123
#411
Open Source Statistical Software in Drug Development: Challenges and
Opportunities
Track 15
Session
LEVEL: ■
CDM, IT
113a
#412
Left to Your Own Devices
Track 16
Symposium
LEVEL: ●
MC, CmbP, PM
125
#413
Track 17
Forum
LEVEL: ●
RA, CP, CR
114 AUD
THURSDAY, JUNE 2810:45–12:15 PM
#414
Strategically Reduce Study Cost by Controlling Study Design Cost Drivers,
with Attention to Studies with Biomarkers
Track 02
Session
LEVEL: ■
CR, PM, FI
105ab
#415
Preferred Provider Relationships: Yesterday’s Obstacles, Today’s Successes,
and Tomorrow’s Vision
Track 03A
Session
LEVEL: ■
OS, CR
111ab
#416
Using Technology to Build Successful Strategic Outsourcing Partnerships
Track 03B
Session
LEVEL: ■
OS, IT, CR
109ab
#417
Strategies for Implementing Dried Blood Spot Drug Development and How
the Technology Supports the 3Rs Principles
Track 04
Session
LEVEL: ●
NC, CP, RD
103b
#418
Medical Writing Competencies and Best Practices in the Global
Environment
Track 06
Symposium
LEVEL: ■
MW, OS, IT
108b
#419
Data Warehousing: Buzz Word or Panacea?
Track 07A
Symposium
LEVEL: ■
CDM, VA, EC
103a
#420
Economic Considerations and Management in the Modern Day Clinical Trial
Track 07B
Symposium
LEVEL: ◆
EC, CDM, FI
103c
#421
Regulatory Handling of Ethnic Factors in Asian Clinical Trial Data #3,
Implication for Simultaneous Global Development (SGD)
Track 08
Session
LEVEL: ■
RA, CDM, CR
107ab
#422
Immunogenicity of Therapeutic Peptides: Regulatory Science Implications
Track 14
Session
LEVEL: ◆
NC, CR, RA
113c
#423
Increasing Clinical Program Success with Modeling and Simulation
Track 15
Session
LEVEL: ●
CR, RD
113a
#424
Building Rapport and Managing Communication Filters for Breakthrough
Collaborations
Track 16
Symposium
LEVEL: ●
PETD, SP, MC
113b
#425
Track 17
Forum
LEVEL: ●
RA, CP, CR
114 AUD
31
NOTES
32
SATURDAY, JUNE 23 — MONDAY, JUNE 25
The information that was made available to DIA as of 4/30/2012 is included in the following agenda. Speaker names identified as “Invited” will be published once
confirmation and disclosure forms are completed. Visit www.diahome.org/DIA2012sessions for the most up-to-date information.
SATURDAY, JUNE 23
MONDAY, JUNE 25
Registration Hours:
Registration Hours:
9:00 AM–5:00 PM
7:00 AM–6:30 PM
Broad Street Lobby
7:00 AM–6:30 PM
Exhibit Hall D Lobby
SUNDAY, JUNE 24
Schedule:
Registration Hours:
8:00 AM–9:00 AM
Registration for Full-day, Morning
Preconference Program/Tutorials
Broad Street Lobby
8:00 AM–6:00 PM
12:30 PM–1:00 PM
Registration for Afternoon Preconference
Program/Tutorials
Broad Street Lobby
3:00 PM–6:00 PM
Broad Street Lobby
Sunday, June 24 — DIA 2012 STUDENT FORUM
3:00 PM–5:00 PM
LEVEL: ●
FORMAT: FORUM
7:15 AM–8:00 AM
Coffee and Breakfast
Terrace Ballroom Lobby
7:15 AM–8:00 AM
Orientation/Networking and Coffee for DIA 2012
Annual Meeting First-timers
Exhibit Hall E Lobby
8:00 AM–9:30 AM
Opening Plenary Session
Terrace Ballroom
9:30 AM–10:00 AM
Coffee Break
Meeting Rooms 108 and 119 Concourse
9:30 AM–10:00 AM
Orientation and Coffee for DIA 2012 Annual Meeting
First-timers
Exhibit Hall E Lobby
10:00 AM–11:30 AM
11:00 AM–6:30 PM
Room 125
DIA 2012 Student Forum "Getting a Job"
11:00 AM–6:30 PM
Exhibit Hall D
CHAIRPERSON
11:30 AM–1:30 PM
Danny A. Benau, PhD
Director, Biomedical Writing Programs, University of the Sciences in
Philadelphia
Exhibit Hall
1:30 PM–3:00 PM
3:00 PM–3:30 PM
Refreshment Break
Exhibit Hall
This year's student forum will concentrate on helpful hints in networking, resume building, and how to interact with potential employers, and
will include information that may not be provided in standard career
counseling. We will also discuss the best ways to take advantage of
the incredible networking opportunity at the DIA 2012 Annual Meeting.
Bring personal business cards and a sample resume.
3:30 PM–5:00 PM
5:00 PM–6:30 PM
Welcome Reception
Exhibit Hall
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers/instructors
are their own opinion and not necessarily that of the organization they represent, or that of the Drug
Information Association. Speakers/instructors and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media is prohibited without prior
written consent from DIA.
Communicating Your Capabilities
Kelleen Flaherty, MS
Assistant Professor, University of the Sciences In Philadelphia
Education Versus Experience
Stephen A. Sonstein, PhD, MS
Director, Clinical Research Administration, Eastern Michigan
University
STAY CONNECTED
For everything DIA 2012 follow us on:
Follow us @DrugInfoAssn
Get real-time announcements and updates. Have a question?
Follow us and ask. Official hashtag is #DIA2012.
Follow us at DrugInfoAssn
Be your own paparazzi. Share your photos with us.
Join our group at Drug Information Association (DIA) —
Biopharmaceutical Professionals.
Stay engaged with new announcements on hot topics,
new speakers and networking events.
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Post your experience on DIA’s wall.
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Check-in to DIA 2012.
Annual Meeting Mobile App
33
Monday, June 25
findings from last year's workshop will be presented along with two brief
presentations from a sponsor and investigative site.
Terrace Ballroom
8:00 AM–9:30 AM
Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and
they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and
no more participants will be admitted. Interested attendees are encouraged to arrive at workshops
early in order to ensure seating. Please note, as a workshop with interactivity, this event will not
be recorded.
Welcome Remarks and
Awards Presentation
Investigator Site Relationship Management: Sponsor Perspective
Nye G. Pelton
Clinical Portfolio Consultant-Enrollment, Eli Lilly and Company
Yves Juillet, MD
Senior Vice President
Industrie Sante, France
Investigator Site Relationship Management: Site Perspective
Deena E. Bernstein, MS
Director of Clinical Research, Sheridan Healthcare, Inc.
Opening Remarks
#102 TRACK 01B – CLINICAL OPERATIONS
Craig H. Lipset
Head of Clinical Innovation
Worldwide Research & Development
Pfizer Inc
10:00 AM–11:30 AM
LEVEL: ◆
Related Interest Area(s): CR, CDM, EC
FORMAT: SESSION
Room 108a
EMRs for Clinical Research: Hype versus Reality –
A Management Primer
CHAIRPERSON
Edward Stephen Seguine, Jr., MBA
CEO, Clinical Ink
Keynote Address
Dean Kamen
Founder and President
DEKA Research & Development Corporation
9:30 AM–10:00 AM
Electronic medical records (EMRs) are often touted as the miraculous solution to reduce clinical trial costs in the future. This session focuses on the
business model implications of using EMRs for clinical research and how
that could affect whether EMRs are really the solution.
COFFEE
Fact versus Fiction: Real Data on EMR Data Quality and Suitability
for Clinical Research
CEO, Clinical Ink
More Common Compliance Challenges Implementing and Using EMRs
Dennis Edward Marquis
Director, Global Quality and Regulatory Compliance, Bristol-Myers
Squibb Company
ANNUAL MEETING OFFERINGS BEGIN
#101 TRACK 01A – CLINICAL OPERATIONS
10:00 AM–11:30 AM
CDER Perspective: Use of EHRs in Clinical Research
Jonathan S. Helfgott, MSc
Consumer Safety Officer, Division of Scientific Investigations, Office of
Compliance, CDER, FDA
Related Interest Area(s): IS, CR, PM
FORMAT: WORKSHOP
CME, Nursing, and PMI PDUs
LEVEL: ■
Room 121c
Investigator Site Relationship Management
Workshop
#103 TRACK 01C – CLINICAL OPERATIONS
CHAIRPERSON
Executive Director, Elite Research Network
10:00 AM–11:30 AM
LEVEL: ■
Related Interest Area(s): CR, PM, MF
FORMAT: SYMPOSIUM
Room 109ab
PMI PDUs
Clinical Supply Chain Symposium
Determining which sites will meet enrollment goals and provide quality
data remains a challenge for sponsors and CROs. In order to improve the
site selection process and decrease the number of zero enrolling sites,
many sponsors/CROs have implemented dedicated staff or entire departments which focus on improving communication with sites to better understand their capabilities, experience, and access to patients. This interactive
workshop offers sponsors, CROs, and investigator sites an opportunity to
openly discuss innovative approaches and organizational models focused
on investigator site relationship management. Discussions will address best
practices of how sponsors and CROs are communicating accurate information to investigator sites and how sites are being selected. Conclusive
CHAIRPERSON
Mary Jo Lamberti, PhD, MA
Senior Project Manager, Tufts Center for the Study of Drug Development,
Tufts University
The symposium will include three presentations. The first will relate key
findings from a Tufts CSDD study on the global supply chain market. The
findings examine the challenges to management of the supply chain in several areas and explores strategies that supply professionals use to optimize
management of the supply chain. The second will examine the role of communication and use of best practices in the relationships between supply
chain providers and sponsors. The third will include a discussion of a systemic approach for monitoring, warning, and forecasting systems (including
34
Monday, June 25
#105 TRACK 02B – PROJECT/PORTFOLIO MANAGEMENT AND
STRATEGIC PLANNING
mid-study supply simulations using real study data) and its impact upon
supply chain efficiencies and costs.
Results of a Global Clinical Supply Chain Market Study
Mary Jo Lamberti, PhD, MA
Senior Project Manager, Tufts Center for the Study of Drug
Development, Tufts University
10:00 AM–11:30 AM
Room 103c
Data Quality by Design (DQbD) to Improve the
Quality of Clinical Trial Data in Multiregional
Clinical Trials (MRCTs)
Optimizing Efficiencies between the Sponsor and IVRS and Drug
Packaging/Distribution Vendors
Leslie Darling
Senior Project Manager, Almac Clinical Technologies
CHAIRPERSON
Khin Maung U, DrMed, MD, MSc
Senior Medical Officer, Division of Cardiovascular Renal Products, Office of
Drug Evaluation I, Office of New Drugs, CDER, FDA
Maximizing Supply Chain Efficiency During the Course of a Study
Through Use of Systematic Monitoring
Andrey Gurachevsky, MSc
Associate Clinical Logistics Leader, PAREXEL International, Germany
Moving towards a data quality by design (DQbD) approach at all stages of
drug development — from planning, design, site selection, study conduct,
data collection and transfer, and statistical analyses — will improve the
quality of data in multiregional clinical trials (MRCTs). This session will bring
together the pharmaceutical industry, data management organization, and
regulatory/review perspectives, with case examples illustrating how the
DQbD approach can be applied to ensure patient safety, promote protocol
adherence, improve the quality and integrity of the data that are generated, processed and analyzed, and enhance the overall efficiency to bring
important therapeutic products to patients who need them.
#104 TRACK 02A – PROJECT/PORTFOLIO MANAGEMENT AND
STRATEGIC PLANNING
10:00 AM–11:30 AM
LEVEL: ■
Related Interest Area(s): QAQC, CDM, CR
FORMAT: SESSION
LEVEL: ■
Related Interest Area(s): PM, RD
FORMAT: SESSION
Room 105ab
PMI PDUs
Overcoming Organizational Resistance to Portfolio
Management
Moving to a Quality by Design, Proactive Approach to Planning and
Executing Clinical Trials: An Industry Collaborative Effort
Guy Andre Mascaro
President, Metrics Champion Consortium
CHAIRPERSON
Peter Ray, MBA
Executive Director, Portfolio and Asset Strategy, Bristol-Myers Squibb Company
Using Quality by Design Approaches in Clinical Trial Planning and
Execution to Improve Patient Safety, Data Quality/Integrity and GCP
Compliance: An Industry Perspective
Nick Astley, MSc
Senior Director, Business Performance and Analytics, Pfizer Inc
Organizations need to tailor their portfolio management approach to their
specific needs and their relative level of organization maturity, considering
the size of the portfolio being managed, the phases of development, and
the degree of resource constraint being faced, all with the right balance of
speed and rigor. The panel discussion will involve a cross-section of practitioners from industry, sharing experiences of what has and has not worked
at their organizations.
Data Quality by Design (DQbD): Regulatory Clinical Review
Perspectives to Improve Data Quality in Multiregional Clinical Trials
(MRCTs)
Khin Maung U, DrMed, MD, MSc
Senior Medical Officer, Division of Cardiovascular Renal Products, Office
of Drug Evaluation I, Office of New Drugs, CDER, FDA
Implementing Portfolio Management at a Large Pharma
Peter Ray, MBA
Executive Director, Portfolio and Asset Strategy, Bristol-Myers Squibb
Company
Introducing Portfolio Strategy Practices at a Growing Biotech
Elizabeth Ng, MBA
Director, Portfolio Strategy, Biomarin Pharmaceuticals
#106 TRACK 03 – INNOVATIVE PARTNERING MODELS AND
OUTSOURCING STRATEGIES
Panelist
Aron Cogswell, MBA
Executive Director, Integrated Business Operations, Pfizer Inc
10:00 AM–11:30 AM
Room 123
LEVEL: ■
PMI PDUs
Related Interest Area(s): OS, SP, PM
FORMAT: WORKSHOP
Best Practices in Managing Alliances: Using the
Balanced Scorecard Methodology to Align Strategy
and Operational Execution
CHAIRPERSON
Tara Mylenski, MBA
Alliance Management, Quintiles
Alliances are usually defined by what each side will contribute, not by what
each hopes to gain. The Balanced Scorecard Management System helps
companies switch their alliance focus from contributions and operations
to strategy and commitment. In this workshop, attendees will learn how
to create a strategy map that integrates a partnership strategy with the
management of operations, as well as how to translate this information
35
Monday, June 25
to a balanced scorecard so that this tool can be used to run effective
governance meetings.
IMI Project Work Package 5: Case Study
Marilyn A. Metcalf, PhD
Director, Benefit Risk Evaluation, GlaxoSmithKline
The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they
are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no
more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in
order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Benefit-risk Communication: From Implicit and Qualitative to
Explicit and Quantitative
Lawrence Phillips, PhD
Visiting Professor of Decision Sciences, Department of Management,
London School of Economics, UK
Facilitator
Kim Fookes
Director, Clinical Operations Strategy, Takeda Global Research &
Development Center, Inc.
Visualizing Benefit and Risk
James Felli, PhD
Research Advisor, Eli Lilly and Company
Facilitator
Kathleen T. Dolan, MBA
Senior Director, CDARO Project Integration, Covance, Inc.
#109 TRACK 07 – PROCESSES AND TECHNOLOGIES FOR
CLINICAL RESEARCH
#107 TRACK 04 – NONCLINICAL AND TRANSLATIONAL
DEVELOPMENT/EARLY PHASE CLINICAL DEVELOPMENT
10:00 AM–11:30 AM
Room 124
10:00 AM–11:30 AM
Room 103a
Related Interest Area(s): CP, NC, CR
LEVEL: ■
FORMAT: SESSION
CME and Nursing
New Ways to Learn What Happens to Patients
AFTER Approval
First-in-human Challenges of Biologics and
Biosimilars
CHAIRPERSON
Stephen A. Raymond, PhD
Chief Scientist, Quality Officer and Founder, PHT Corporation
CHAIRPERSON
This session explores new ways to help physicians monitor and support
individual patients for whom they prescribe medications. A physician will
present on the topic, and the chair is seeking discussion from attendees
with medical experience.
Royce A. Morrison, MD, MS
Principal Investigator/Chief Medical Officer, Comprehensive Clinical
Development
Prepare to move your biologic (or biosimilar) drug to a First-in-Human
study. Hear from leading preclinical and Phase I investigators on how to
identify safety risks and plan to mitigate them.
How Patients and Physicians Can Obtain Actionable Information
Now and Possible Improvements on the Horizon
Donald C. Manning, MD, PhD
Chief Medical Officer, Adynxx, Inc.
Biologics and Biosimilars: First-in-human Challenges
Development
FDA Point of View
Melissa A. Robb, RN
Associate Director, Regulatory Affairs, Office of Medical Policy
Initiatives, CDER, FDA
Nonclinical Pre-IND Experiments: Biologics Experience Informing
Phase 1 Trial Designs
Lauren E. Black, PhD
Senior Scientific Advisor, Charles River Laboratories
Using Patient Reported Outcomes to Assess Drug Safety and
Tolerability
Chad Gwaltney, PhD
Senior Scientist, PRO Consulting
Biologics Clinical Trials: Experiments Not Demonstrations —
The Importance of Active Thinking
Cyril P. Clarke, MD
Vice President Translational Medicine, ICON PLC, UK
#110 TRACK 08A – REGULATORY AFFAIRS AND SUBMISSIONS
10:00 AM–11:30 AM
#108 TRACK 06 – MEDICAL WRITING AND MEDICAL
COMMUNICATIONS
10:00 AM–11:30 AM
Related Interest Area(s): CP, IT, CDM
LEVEL: ◆
FORMAT: SESSION
CME, Pharmacy, and Nursing
Room 115c
LEVEL: ■
Pharmacy
Related Interest Area(s): RA, CR, PM
FORMAT: FORUM
Transforming Regulatory Information Into Actionable
Regulatory Intelligence for Emerging Markets
Related Interest Area(s): MW, RA, CP
LEVEL: ◆
FORMAT: SESSION
Room 108b
Advancing Benefit-risk Visualization and
Communication
CHAIRPERSON
CHAIRPERSON
Industry representatives and an emerging market health authority will
discuss gathering and management of regulatory intelligence from rapidly
evolving emerging markets.
Kim M. Quaintance
Senior Director, Global Regulatory Policy and Intelligence, Eisai Inc.
Marilyn A. Metcalf, PhD
Director, Benefit Risk Evaluation, GlaxoSmithKline
This session will provide a discussion of the continuum of benefit-risk
assessment models, ranging from personal mental models to more formal
qualitative and quantitative models.
Working With Emerging Markets: A Case Study
Linda F. Bowen, MS, RAC
Head, Regulatory Policy and Intelligence-US, Sanofi
36
Monday, June 25
Gathering and Leveraging News from Emerging Markets
Brooke Casselberry, MS
Senior Manager, Regulatory Affairs and Writing Services, Liquent, Inc.
#113 TRACK 10 – PUBLIC POLICY/HEALTH CARE
COMPLIANCE/REGULATORY LAW
Panelists
10:00 AM–11:30 AM
Augustina Bisio
Director, Drug Evaluation Agency, ANMAT, Argentina
Room 120bc
Clinical Trials on Trial: Potential Legal Liability
Arising from Clinical Trials
Related Interest Area(s): CP, RA, IS
Representative Invited
Manager, Research and Clinical Trials, ANVISA, Brazil
CHAIRPERSON
Mark C. Hegarty, JD
Partner/Attorney, Shook, Hardy & Bacon LLP
#111 TRACK 08B – REGULATORY AFFAIRS AND SUBMISSIONS
10:00 AM–11:30 AM
Room 119b
In this workshop, experienced lawyers will conduct a mock trial involving
issues that may arise in clinical trial lawsuits. The mock trial will include
opening statements and closing arguments, as well as realistic direct and
cross-examination of the primary witnesses in the case, including video
evidence. At its conclusion, the lawyers will entertain questions about the
mock trial.
Related Interest Area(s): RA, CR, PPLCC
LEVEL: ■
FORMAT: FORUM
Pharmacy
Effective Switching from Rx to OTC Status:
Maximizing Revenue and Profit From Off-Patent
Products
CHAIRPERSON
Peter M. Lassoff, PharmD
Vice President and Head of Global Regulatory Affairs, Quintiles, UK
John M. Isidor, JD
Senior Director and Co-Founder, Schulman Associates IRB, Inc.
This session will provide an insight into the complex regulatory issues
associated with switching of medicines to OTC status and strategic insights
into how to use OTC switching to extend protection against competitor
companies as patent expiry approaches.
Jeffrey N. Gibbs, JD
Director, Hyman Phelps & McNamara, PC
Adrienne Hernandez, JD
Associate, Shook, Hardy & Bacon LLP
EU Perspective
FDA Point of View
Charles J. Ganley, MD
Director, Office of Drug Evaluation IV, Office of New Drugs, CDER, FDA
#114 TRACK 11 – COMPLIANCE TO GOOD CLINICAL PRACTICE
(GCP), GOOD LABORATORY PRACTICE (GLP), AND
QUALITY ASSURANCE (QA)
US Industry Point of View: Rx to OTC Switch
David Schifkovitz
Vice President, Regulatory Affairs, GlaxoSmithKline Consumer Healthcare
10:00 AM–11:30 AM
Related Interest Area(s): CR, CP, QAQC
FORMAT: SESSION
LEVEL: ■
Room 119a
#112 TRACK 09 – MEDICAL DIAGNOSTICS AND DEVICES
10:00 AM–11:30 AM
LEVEL: ●
FORMAT: WORKSHOP
CHAIRPERSON
John Poland, PhD
Senior Director, Regulatory Policy and Compliance, Covance Clinical
Development Services, UK
Related Interest Area(s): RA, CR, RD
LEVEL: ■
FORMAT: SESSION
Room 118c
Companion Diagnostics: Current and Future
Developments
Latest progress in FDA and EMA initiatives on developing a new approach
to quality in clinical trials, together with current expectations and practical
examples from recent experience, will be analyzed and discussed.
CHAIRPERSON
A View from Industry
Mike Sobczyk, MSc
Senior Director, Regulatory Compliance, Gilead Sciences, Inc.
Paul Van Dongen, LLM, MS
Lawyer, NautaDutilh N.V., Netherlands
Companion diagnostics, in vitro diagnostics that accompany treatments, are
a major development in personalized medicine. This session looks into the
regulatory and scientific aspects of this innovative approach.
A View from the EMA
Fergus Sweeney, PhD
Head of Sector, Compliance and Inspection, European Medicines
Agency, European Union
IVDs as Companion Diagnostics in Personalized Medicine: A Medical
Device Perspective
Barry S. Sall, RAC
Principal Consultant, PAREXEL Consulting
A View from the FDA
Leslie Ball, MD
Acting Director, Office of Scientific Investigations, CDER, FDA
37
Monday, June 25
#115 TRACK 12 – PHARMACEUTICAL QUALITY
10:00 AM–11:30 AM
#117 TRACK 14B – CLINICAL SAFETY AND
PHARMACOVIGILANCE
Related Interest Area(s): CMC, RA, MF
LEVEL: ●
FORMAT: FORUM
Pharmacy
10:00 AM–11:30 AM
Room 122b
Room 118a
Approaches to Postapproval Pediatric Safety
Surveillance
CHAIRPERSON
Elaine Morefield, PhD
Deputy Office Director, Office of New Drug Quality Assessment, CDER, FDA
CHAIRPERSON
Robert Reynolds, DrSc, MSc, FISPE
Vice President, Global Head, Epidemiology, Pfizer Inc
This forum will discuss ICH topics related to pharmaceutical quality, including the new guideline for drug substances (Q11) and the Q8, Q9, and Q10
points to consider document.
This session describes the use of observational data sources and methods,
including electronic health care data, cohorts and registries to conduct
postapproval safety surveillance in pediatric populations.
Q11 Update: Development and Manufacture of Drug Substances
(Chemical Entities and Biotechnological/Biological Entities)
Betsy P. Fritschel
Director, Enterprise Regulatory Compliance, Johnson & Johnson
Data Sources and Methodological Challenges: Conducting
Epidemiologic Pediatric Safety Studies
Susan Oliveria, DrSc, MPH, FISPE
Principal Epidemiologist, EpiSource
Q3D: Metal Impurities Guidance
John F. Kauffman, PhD, MBA
Research Chemist, Division of Pharmaceutical Analysis, Office of
Pharmaceutical Science, Office of Translational Sciences, CDER, FDA
Designing a Comprehensive RMP for Pediatric Drug Approval:
Example in Pediatric Rheumatology
Rachel E. Sobel, DrPH
Specialty Care & Established Products BU Group Head, Epidemiology,
Worldwide Safety Strategy, Pfizer Inc
Update on the Quality Implementation Working Group (QIWG)
Points to Consider Document
Elaine Morefield, PhD
Deputy Office Director, Office of New Drug Quality Assessment,
CDER, FDA
The Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES):
Design & Implementation of a Pragmatic Incident Cohort Study
John March, MD, MPH
Director, Division of Neurosciences Medicine, Duke Clinical Research
Institute
#116 TRACK 14A – CLINICAL SAFETY AND
PHARMACOVIGILANCE
10:00 AM–11:30 AM
Related Interest Area(s): CP, CDM, EC
FORMAT: SESSION
LEVEL: ■
Related Interest Area(s): AP, RA, MC
LEVEL: ●
FORMAT: FORUM
#118 TRACK 15 – STATISTICAL SCIENCE AND QUANTITATIVE
THINKING
Room 121ab
The Impact of Social Media on Product Promotion
and Pharmacovigilance
10:00 AM–11:30 AM
Related Interest Area(s): ST, RA, OS, BT
FORMAT: FORUM
LEVEL: ■
Room 113a
Hot Topics in Statistics: Industry, CRO, Academic,
and Regulatory Perspectives
CHAIRPERSON
Julie Anne Zawisza, MA
Director, Office of Communications, CDER, FDA
CHAIRPERSON
Social media creates challenges and opportunities for the promotion and
safety of drugs and other medical products. FDA and industry are working
to optimize truthful product information and ways to gather adverse event
data utilizing this resource.
Lisa M. LaVange, PhD
Director, Office of Biostatistics, Office of Translational Science, CDER, FDA
What do we need to do and think about in order to "push the statistical
envelope"? The most pressing issues facing statisticians involved in the
development of new drugs and biologics today will be discussed from
a variety of viewpoints. Following a brief introduction from a regulatory
perspective, speakers representing the statistical leadership of a large
pharmaceutical company, a mid-sized biotechnology company, and a global
contract research organization will discuss what they perceive to be critical
issues in statistical methodology and/or application. The impact of these
hot topics on drug development and regulatory decision-making, both
locally and globally, as well as ideas for addressing each issue will be discussed. An academic perspective, particularly with respect to ways forward
in developing real-world solutions, will also be provided.
FDA Perspective: Advertising
Thomas W. Abrams, MBA, RPh
Director, Office of Prescription Drug Promotion, CDER, FDA
FDA Perspective: Pharmacovigilance
Gerald J. Dal Pan, MD
Acting Director, Office of Surveillance and Epidemiology, CDER, FDA
Industry Perspective: Advertising
Paul James Savidge, JD, MBA
Vice President and Associate General Counsel, Bristol-Myers Squibb
Company
Panelists
Stephen J. Ruberg, PhD
Distinguished Research Fellow; Scientific Leader, Advanced Analytics,
Industry Perspective: Pharmacovigilance
Elizabeth E. Garrard, PharmD, RPh
Chief Safety Officer, Drug Safety Alliance, Inc.
Laura J. Meyerson, PhD, MA
Vice President, Biostatistics, Biogen Idec
38
Monday, June 25
Andrew Garrett, PhD, MSc
Vice President, Global Biostatistics, Medical Writing and Regulatory
Affairs, Quintiles, UK
Hans-Georg Eichler, MD, MSc
Senior Medical Officer, European Medicines Agency, European Union
Aginus A. W. Kalis, MD
Executive Director, Medicines Evaluation Board, Netherlands
Discussant
Gary G. Koch, MS
Director, Biometric Consulting Lab. Biostatistics; Professor, Biostatistics,
University of North Carolina at Chapel Hill
#121 TRACK 17B – GLOBAL REGULATORY
10:00 AM–11:30 AM
#119 TRACK 16 – PROFESSIONAL DEVELOPMENT
10:00 AM–11:30 AM
LEVEL: ■
Room 116
Pediatric Drug Development Progress: 15 Years
Later and Across the Globe
Related Interest Area(s): CR, RD, CP
FORMAT: SESSION
Room 117
Translational Medicine in Africa: Challenges and
Opportunities for Product Development
CHAIRPERSON
William J. Rodriguez, MD, PhD
Science Director, Office of Pediatric Therapeutics, Office of the
Commissioner, FDA
CHAIRPERSON
Nyasha Bakare, MD, MPH
Global Medical Safety Physician, Infectious Diseases, Janssen Research &
Development, LLC
Cooperative efforts between EMA and FDA have resulted in addressing
many study issues. The benefits of these exchanges and existing issues with
extrapolation and formulations will be discussed.
Africa is a critical venue in view of the increased focus on novel tools to
prevent, diagnose, and treat diseases disproportionately affecting low and
middle-income countries. This session will discuss key topics around product development in Africa.
Extrapolation from Adult Clinical Data to Pediatric Population(s):
FDA Experience
Commissioner, FDA
Translational Medicine: To Enhance Health Care Delivery and Better
Patient Care
Aamir Shahzad, MD, DrMed
Secretary General and Director of Administration, International Society
For Translational Medicine (ISTM), Austria
Extrapolation from Adult Clinical Data to Pediatric Population(s):
EMA Experience
Agnès Saint-Raymond, MD
Head, Human Medicines, Special Areas, European Medicines Agency,
European Union
Regulatory Challenges for Translational Medicine in Africa
Paul K. Tanui
Senior Programme Officer, NEPAD Planning and Coordinating Agency,
South Africa
Formulation Strategies for Pediatric Dosage Forms: FDA Experience
Mansoor Khan
Director, Division of Product Quality Research, Office of Testing and
Research, Office of Pharmaceutical Science, CDER, FDA
The Conduct of Multi-country Clinical Trials in Africa: Opportunities
and Challenges
Annalene Nel
Chief Medical Officer, International Partnership For Microbicides,
South Africa
Formulation Strategies for Pediatric Dosage Forms: EMA Experience
European Union
Advantages of Sharing Information Prospectively with Overseas
Colleagues
Commissioner, FDA
#120 TRACK 17A – GLOBAL REGULATORY
10:00 AM–11:30 AM
Related Interest Area(s): RA, PPLCC, ST
LEVEL: ■
FORMAT: FORUM
Related Interest Area(s): RA, CP, CR
FORMAT: FORUM
LEVEL: ■
CME and Nursing
Room 113c
European Town Hall: Part 1 of 2 – Hot Topics in
Europe
#122 TRACK 18 – RARE/NEGLECTED DISEASES
CHAIRPERSON
Guido Rasi, MD
Executive Director, European Medicines Agency, European Union
10:00 AM–11:30 AM
Related Interest Area(s): CR, RD, SP
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Room 111ab
Drug Development Strategies for Integrating
Academia, Non-governmental Organizations
(NGOs), and Industry Based on Experience in
Neglected and Infectious Diseases
Part 2 of this forum will take place on Monday, June 25 at 3:30 PM.
The European medicines system offers different ways of bringing new
medicines to the patient, whether through the European Medicines Agency
centralized route or through the European national agencies' decentralized
route. This first part of the European Town Hall offers the possibility to hear
from the senior leadership from both the EMA and national agencies on a
number of important topics in European regulatory network. A second part
offers insights on practical interactions with the European system.
CHAIRPERSON
Melynda Watkins, RAC
Manager, Product Development, Clinton Health Access Initiative (CHAI)
This session will describe drug development strategies for integrating
academia, non-governmental organizations (NGOs), and industry based
Submit questions in advance to [email protected]
Subject: European Town Hall
39
Monday, June 25
on experience for the development of drugs for neglected and infectious
diseases in the global health arena.
#124 TRACK 22A – WHITE PAPER SHOWCASE
Discovery and Development of Novel Orally-active Compounds for
Treatment of African Sleeping Sickness: Challenges and Solutions to
Drug Discovery for a Neglected Tropical Disease
Robert T. Jacobs, PhD
Director of Chemistry, SCYNEXIS, Inc.
Related Interest Area(s): CP, PM, SP
LEVEL: ●
FORMAT: SESSION
10:00 AM–11:30 AM
Room 125
The New Health Report 2012:
Rethinking the Risk Equation in Biopharmaceutical Development and Delivery
CHAIRPERSON
Delivering Innovation for Neglected Diseases: A Biotech Perspective
Eric Easom
Program Leader, Neglected Diseases, Anacor Pharmaceuticals
Adam Istas
Director, Thought Leadership, Quintiles
Based on a survey of biopharmaceutical executives, payers, patients and
investors, The New Health Report 2012 builds upon previous calls for
multi-stakeholder collaboration by exploring the often misunderstood
element of risk as it relates to biopharmaceutical development and
delivery.
Integrating Cross-functional Global Groups in Drug Development for
Neglected Diseases: A Case Study
Melynda Watkins, RAC
Manager, Product Development, Clinton Health Access Initiative (CHAI)
Brought to you by Quintiles.
#123 TRACK 21 – LATE BREAKER
10:00 AM–11:30 AM
Room 103b
**Attendee badges scanned for this White Paper Showcase will be shared with the company
hosting this offering. If you prefer not to have your badge scanned, please inform the DIA
staff member.
Related Interest Area(s): CP, CDM, EC, IT
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Panelists
John J. Doyle, DIPH, MPH
Vice President and Practice Leader for Market Access, Quintiles
Standards for Patients: Collaborations to Innovate
Therapy Development
Patrick Jordan, MBA
Vice President, Global Customer Solutions, Quintiles
CHAIRPERSON
Bron Witt Kisler
Vice President, Strategic Initiatives, CDISC
This session will highlight the CDISC/C-Path Partnership, which has
launched therapeutic area projects to develop disease-specific standards,
as well as provide an overview of therapeutic area data standards, the FDA
regulatory viewpoint and roadmap for developing priority therapeutic area
standards, and important viewpoints from a practicing clinician and patient
advocate. Nine projects are currently underway addressing cardiovascular
disease, infectious diseases, neurological disorders and kidney disease, and
these have proven how clinicians, researchers, and patient advocates play
a pivotal role in the often technical world of standards development. The
blending of clinical knowledge, patient experiences and technical expertise
into the standards development process is the key to ensuring that standards ultimately benefit the patient.
#150 TRACK 22B – WHITE PAPER SHOWCASE
Related Interest Area(s): CR, RA, SP
NEW TIME: 10:00 AM–11:30 AM LEVEL: ●
FORMAT: SESSION
Room 13B
Free Agency is Here: Exploring Workforce
Impact on Clinical Outsourcing
CHAIRPERSON
Alan Edwards
Vice President, Americas Product Group, Science, Kelly Services, Inc.
In the past decade clinical trials have become increasingly costly and
more therapeutically specific, both yielding new challenges in the global
coordination of these programs. Additionally, the need for global population engagement, combined with increasing regulatory requirements,
has stretched the capability of current business models, particularly
as it pertains to efficient management of a workforce to achieve your
company's strategic initiatives.
FDA Regulatory Priorities for Therapeutic Area Data Standards
Charles K. Cooper, MD
Medical Officer, Office of Translational Sciences, CDER, FDA
CDISC and C-Path Partnership: The Coalition for Accelerated
Standards and Therapies (CFAST)
Bron Witt Kisler
Vice President, Strategic Initiatives, CDISC
Brought to you by Kelly Services, Inc.
staff member.
Mark Lanfear
Global Practices Leader, Clinical Operations, Kelly Services, Inc.
11:30 AM–1:30 PM
LUNCHEON
Exhibit Hall
40
Monday, June 25
12:00 PM–12:45 PM
EMC Corporation Innovation Theater
Related Interest Area(s): RD, IT
SPECIA
SESSIO L
N
1:30 PM–3:00 PM
Related Interest Area(s): AP, MA
FORMAT: SYMPOSIUM
CME and Nursing
LEVEL: ■
Room 108a
Social Media: The Promise and Pitfalls for Patient
Recruitment
See the map located on the back of the
Exhibitors tab for location.
Innovation in R&D and Commercialization
through Big Data Analytics
CHAIRPERSON
Jane E. Myles, MS
Global Head, Patient Recruitment, Genentech, A Member of the Roche Group
The transforming R&D environment demands tight coordination of a
complex network of partners and suppliers, as well as information
resources. Blended cloud environments (public, private, community, and
hybrid) will provide rapid, secure and dynamic collaboration areas for
organizations and partners. The ability to analyze and synthesize this data
for commercialization will be a differentiator for high performing firms.
Social media has huge potential as a new set of tools to drive patient
recruitment. How do you use it and what happens when you do? In this
symposium, we will offer both successes and lessons learned from trying
social media as a recruitment strategy.
We believe that clinical and research organizations have an opportunity
to utilize these new IT consumption models for a competitive advantage
in the marketplace. EMC will discuss our innovations in 3 areas that we
feel will be critical for driving R&D and commercial success.
Is Social Media the New Technology for Helping Patients Find
Clinical Trials?
Richard Mayewski
Global Trial Optimization Specialist, Merck & Co., Inc.
Collaboration: Seamlessly share information assets & develop knowledge in real time.
Finding the "ePatient" for Your Clinical Trial
Rodney William Butt, MBA, MSc, MT
Principal Consultant, Clinical Operations, Hamilton Medical Consultants
Group, Canada
Fast Data: Leverage resources distributed across the partner network,
with ability to flexibly aggregate, process, and analyze large quantities
of information.
When Social Media Undermines Clinical Trial Performance
Elizabeth A. Moench
President and Chief Executive Officer, MediciGlobal
Cloud: Flexibly engage partners and information sources anywhere in
the world, at any time.
STRATEGIC PLANNING
1:30 PM–3:00 PM
LEVEL: ◆
Related Interest Area(s): CR, FI, PM
FORMAT: SESSION
1:30 PM–3:00 PM
Room 109ab
PMI PDUs
Increasing Protocol Complexity Places Challenges
on Research Site Budgeting
LEVEL: ■
Related Interest Area(s): RA, CR
FORMAT: SESSION
Room 103c
Quality by Design in Clinical Development:
Blessing or Burden?
CHAIRPERSON
CHAIRPERSON
Michael Jay, MA
Vice President, RxTrials, Inc.
Barbara Leishman, MA
Head, Quality Risk Management–Safety Science, F. Hoffmann-La Roche Ltd.,
Switzerland
The challenges that research sites face with respect to clinical trial budgeting is that they do not know how much the different activities cost or how
to synthesize them into one overall budget plan. Additionally, a number
of factors have contributed to the deceleration of grants ranging from
sponsors funding fewer clinical trials, sponsors spending more on latephase clinical trials overseas, to more complex protocols requiring smaller
numbers of patients per investigative site and more difficult to administer.
This session will focus solely on clinical trial budgeting at the site level.
Exploration of the costs of personnel, recruitment, startup, close-out activities, monitoring, document storage, and more will be thoroughly examined
and combined into one overall trial budget.
By reviewing current regulatory and industry initiatives, this session aims
to provide clarity in a changing environment, and provide the impetus and
information to support those seeking to apply QbD/QRM to add value in
their own environment.
Quality by Design: The Winding Road to Quality as a Culture in
Jeffrey S. Kasher, PhD
Vice President, Global Clinical Development, Eli Lilly and Company
Can the Pharmaceutical Industry Afford to Implement QRM?
Kenneth J. Sprenger, MD, PhD
Executive Director, Medicine Team Leader, Pfizer Inc
Sites Challenged with Securing Grants Amidst Increasing Protocol
Complexity
Joan A. Chambers
Chief Operating Officer, CenterWatch, Inc.
FDA Perspective
Leslie Ball, MD
A Site’s Perspective on the Challenges of Clinical Trial Budget
Negotiation
Michael Jay, MA
Vice President, RxTrials, Inc.
Challenges in Clinical Trial Budgeting: A Sponsor’s Perspective
Allison Burmeister, MBA
Clinical Business Operations Manager, Janssen AI R&D, LLC
41
Monday, June 25
STRATEGIC PLANNING
1:30 PM–3:00 PM
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, PETD
FORMAT: WORKSHOP
1:30 PM–3:00 PM
Room 121c
Get the Team to Take Charge!
Room 124
Renal Impairment Studies Design, Conduct, and
Analysis
CHAIRPERSON
John A. Faulkes, MSc
Consultant, TeamCommunications Development, UK
CHAIRPERSON
Harry W. Alcorn, Jr.
Chief Scientific Officer, DaVita Clinical Research
This workshop will enable people in a project environment to make teams
more self-starting, proactive, and act with full ownership of business objectives. It will feature simulation case studies, small-team exercises, and learning from others’ experiences.
Renal studies are a critical part of an IND submission (medications and renal
clearance) with our aging population and increase in the chronic kidney
disease (CKD) population. Study design and implementation is critical to
quality data and timelines being met by the site. This forum will include presenters from the FDA, industry and a clinical trial site who have knowledge,
experience, and publications that support their position in the industry and
current information as it relates to the FDA guidelines, industry needs, and
clinical trial site conduct.
CKD Studies Conduction, Specialty Population Recruitment and
Enrollment
Harry W. Alcorn, Jr.
Chief Scientific Officer, DaVita Clinical Research
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): NC, CR, RA
FORMAT: FORUM
LEVEL: ●
CME and Nursing
Related Interest Area(s): OS, PM, SP
FORMAT: SESSION
A Comparison of Renal Function Estimation Equations
Nancy Xu, MD
Medical Officer, Division of Cardiovascular and Renal Products, Office of
New Drugs, CDER, FDA
Room 105ab
PMI PDUs
Managing a Complex Outsourcing Collaboration
CHAIRPERSON
Andrew Eibling, MBA
Vice President, Alliance Management, Covance, Inc.
Design, Conduct, and Interpretation of Cinical Studies in CKD Patients
Marc Pfister, MD
Chief Medical Officer, Quantitative Solutions, Inc.
Pharma/CRO relationships have emerged as a critical success factor in the
continued growth of the pharma industry. However, managing these relationships continues to be a challenge for many companies. A groundbreaking pharma/CRO partnership has demonstrated that strategic partnerships
can deliver value beyond traditional transactional models. Best practices
have emerged regarding the management of such a complex relationship,
and this session will review key success factors as well as a model for
managing large complex partnerships, examining metrics, governance, and
transaction versus collaboration.
COMMUNICATIONS
1:30 PM–3:00 PM
Room 108b
Related Interest Area(s): MW, CP, RA
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Wrangling the Bestiary of Safety Documents:
Coordination and Integration across Multiple
Requirements
Bringing Structure to Life: The Anatomy of Successful Governance
Adrienne R. Takacs, PhD
Senior Director, LRL Operations, Eli Lilly and Company
CHAIRPERSON
Aaron Van Etten, MS
Global Regulatory Writing, Amgen Inc.
Collaborative Challenges: Skill Sets and Behaviors Essential for
Success
Andrew Eibling, MBA
Vice President, Alliance Management, Covance, Inc.
Medical writers' approaches to authoring pre- and postmarketing safety
documents will be discussed with emphasis on meeting multiple, international requirements for products at various stages of development.
Framing the Challenge: Understanding the Current Environment and
Various Outsourcing Models
Andy Lee, MA
Senior Vice President, Global Clinical Operations, Genzyme Corporation
A Writer’s Perspective on Safety Documents Written Prior to the
Marketing Application
Sandra J. Hecker, RAC
US Agent; Regulatory Consultant, Hecker & Associates, LLC
Developing Potential Solutions: Value Creation
Jacques Mulder
Principal, Pharmaceutical R&D Practice Leader, Deloitte Consulting LLP
A Writer’s Perspective on Safety Documents in the Peri-approval
Period
Michael D. Hoffman, MS
Senior Director, Medical Writing and Regulatory Operations, United
BioSource Corporation
A Writer’s Perspective on Safety Documents After Approval
Jan Sechler, PhD
Manager, Regulatory Medical Writing, Janssen Research &
Development, LLC
42
Monday, June 25
#132 TRACK 07A – PROCESSES AND TECHNOLOGIES FOR
CLINICAL RESEARCH
1:30 PM–3:00 PM
1:30 PM–3:00 PM
Related Interest Area(s): CDM, IT, EC
LEVEL: ●
FORMAT: SESSION
LEVEL: ■
FORMAT: FORUM
Room 113c
Pharmacy
Room 103b
Capitalizing on Biometric Efficiencies: A Look at
Data Start-up, Capture, Monitoring, and Reporting
CHAIRPERSON
Joseph C. Scheeren, PharmD
Senior Vice President, Head Global Regulatory Affairs, Bayer Healthcare
Pharmaceuticals
CHAIRPERSON
Jessica Merryfield
Manager, Project Management, Premier Research Group Ltd.
This forum will explore the challenges of biosimilars in light of the recent
policy developments in the US, EU, and Asia. Participants will hear from a
roundtable of authorities on how to address biosimilars and the opportunities for the future.
This session will explore efficient approaches for streamlining biometrics
activities. Best practices to ensure successful biometric deliverables from
start-up to study completion will be shared, including data capture and
monitoring solutions.
FDA Point of View: Developing Biosimilar Products
Associate Director for Biosimilars, Office of New Drugs, CDER, FDA
Managing Biometric Timelines: Key Factors to Success
Jessica Merryfield
Manager, Project Management, Premier Research Group Ltd.
Asia Point of View
Electronic Patient-reported Outcomes (ePRO): Equivalent to Paper?
Or Better and More Versatile?
Brian Tiplady, PhD
Senior Clinical Scientist, invivodata, Inc., UK
EMA Point of View
Peter J. Richardson, PhD
Head of Biologics, Quality of Medicines Sector, European Medicines
Implementation, Benefits and Results of Centralized Monitoring
James DeSanti
President and CEO, PharmaVigilant
#133 TRACK 07B – PROCESSES AND TECHNOLOGIES FOR
CLINICAL RESEARCH
1:30 PM–3:00 PM
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): OS, RA
FORMAT: SESSION
Room 115a
New Challenges from Outsourcing of Regulatory
Operations
Related Interest Area(s): CDM, CR, IT
LEVEL: ■
FORMAT: FORUM
CME and Nursing
Room 103a
Implications of Mobile Health and Clinical Research
Studies
CHAIRPERSON
Steve R. Hasler
CEO, Originex Limited, UK
CHAIRPERSON
With the focus on cost reduction, the industry is progressing outsourcing
of regulatory operations business processes, bringing new challenges and
issues. This session will focus on how these are being overcome and the
business benefits that result.
Nancie E. Celini, DrPH, MPH
Chief Learning Consultant, CAB Inc.
What is mHealth? What does mHealth offer (or threaten) for clinical
research? This forum presents diverse accounts of mHealth at work in the
real world in order to consider the implications (both promise and threats)
for the conduct of clinical research trials.
The Benefits and Challenges in Regulatory Outsourcing
Steve R. Hasler
CEO, Originex Limited, UK
Soldiers and Babies: Learning What is Happening to Them So Timely
Actions Can be Taken — A View From the Field
Ronald K. Poropatich, MD
Deputy Director, Telemedicine and Advanced Technology Research
Center (TATRC), US Army Medical Research and Material Command
(USAMRMC)
Practical Experience, Results, and Key Learnings
John M. Joseph, III, MA
Executive Director, Global Dossier Management, Bristol-Myers Squibb
Company
Experience to Date and Future Direction
Allen Jones
Director, Global Regulatory Operations, GlaxoSmithKline
Crowd Sourced Health Care Studies: Implications for Pharma
David Lee Scher, MD, FACC
Director, DLS Healthcare Consulting, LLC
Disruptive Innovation: Virtual Clinical Trials — Fact or Fiction
Miguel Orri, MD
Senior Director, Pfizer Ltd., UK
43
Monday, June 25
#136 TRACK 08C – REGULATORY AFFAIRS AND SUBMISSIONS
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): RA, MF, PM
FORMAT: SESSION
1:30 PM–3:00 PM
Room 119b
Regulatory Strategies to Accelerate Approval
in Emerging Markets Considering the Growing
Complexity of Requirements and Supply Chains
Room 118c
Where is the 510(k) Today
CHAIRPERSON
Heather Rosecrans
Vice President, Regulatory Affairs, Medical Device Manufacturers Association
(MDMA)
CHAIRPERSON
Elaine Whiting
Associate Director, Regulatory Policy, Intelligence and Labelling, AstraZeneca
Pharmaceuticals LP, UK
This session will discuss the 510(k) Program, post IOM 510(k) Report,
and where FDA stands on the list of their action items related to the
510(k) Program.
This session is designed to discuss the strategies for accelerating approval
and market access in emerging markets in the context of increasingly
demanding regulatory requirements and the growing complexity of manufacturing supply chains.
The State of the 510(k) Pathway Post-IOM Report
Barry S. Sall, RAC
WHO Perspective
Lembit Rago, MD
Coordinator, Quality Assurance and Safety for Medicines, World Health
Organization (WHO), Switzerland
MDUFA III: Efforts to Improve Predictability and Transparency
Mark B. Leahey, JD
President and CEO, Medical Device Manufacturers Association (MDMA)
EMA Perspective
Francesca Cerreta, PharmD, MPharm, MS
Scientific Administrator, European Medicines Agency, European Union
#139 TRACK 10 – PUBLIC POLICY/HEALTHCARE
Regulatory Strategies to Accelerate Approval in Emerging Markets
Fraser Stodart
Senior Director, Global Regulatory Affairs, Emerging Markets, Eisai
Limited, UK
1:30 PM–3:00 PM
LEVEL: ■
LEVEL: ■
Pharmacy
Related Interest Area(s): RA
FORMAT: SESSION
Room 120bc
Regulatory Collaboration/21st Century Innovation –
Views of the Heads of Health Canada, the
European Medicines Agency, and the US FDA
#137 TRACK 08D – REGULATORY AFFAIRS AND SUBMISSIONS
1:30 PM–3:00 PM
Related Interest Area(s): RA, PPLCC, CmbP
LEVEL: ●
FORMAT: SESSION
CHAIRPERSONS
Related Interest Area(s): CR, PM, RD
FORMAT: SESSION
Marie Allison Dray, MA, MBA
President, International Regulatory Affairs Group LLC
Room 116
Challenges and Opportunities for Drug
Development in China
Murray M. Lumpkin, MD, MSc
Commissioner's Senior Advisor and Representative for Global Issues,
Immediate Office of the Commissioner, Office of International Activities
and Strategic Initiatives, FDA
CHAIRPERSON
Laura Hong, MD, PhD
President, SAPA (Sino-American Pharmaceutical Professionals Association)
After working to harmonize technical requirements under the ICH, establishing confidentiality arrangements, collaborating on inspection pilots,
exchanging working level scientific and regulatory policies, procedures, and
reports, and implementing technical level "clusters" of agency reviewers
… what are the next challenges and next steps in 21st century regulatory
cooperation?
This session will provide enriched discussions on the current status and
unique challenges for drug development in China, the increasing role
of China in global development of drug products, and opportunities for
China’s SFDA and pharmaceutical industry to improve, succeed, and excel.
In this session, the audience will be privileged to hear views from the
leaders of three of the most influential drug regulatory agencies — HPFB
of Health Canada, the European Medicines Agency, & the US FDA — on
these important issues.
This session is hosted by Sino-American Pharmaceutical Professionals
Association (SAPA).
CEO and Chief Scientific Officer, Zhejiang Beta Pharma Inc., China
đƫHow do agencies meet their domestically-focused mission in an increasingly global environment?
Chief Scientific Officer, Pharmaron Beijing, Co. Ltd., China
đƫWhat will regulatory collaboration look like as we go further into the 21st
century?
Vice President, Head of R&D, Johnson & Johnson, China
đƫHow do you integrate local community perspectives and needs into
efforts to increase collaborative efforts with other agencies to innovate
public health worldwide?
đƫHow does an agency share international values with its primarily local
constituents, especially parliamentary overseers?
44
Monday, June 25
matches a series of one hour live and web-based tutorials with the regulations, standards, guidance, advisories, and compliance program guidance
from a variety of regulatory agencies. The fulfillment of training requirements, leads to a well prepared organization that can withstand regulatory
scrutiny. In this regard, the speakers will review GLP inspection readiness,
including what documentation is expected to be readily available and how
to avoid inspection findings.
Panelists
Point of View from Health Canada
Paul Glover, MBA
Assistant Deputy Minister, Health Products and Food Branch,
Health Canada
Point of View from the FDA
Margaret Hamburg, MD
Commissioner, FDA
Which Is the Right Laboratory Standard: GLP, GCLP, ISO, SLMTA?
Janet E. Robinson, DrSc, RAC
Global Director, Laboratory Sciences and Regional Director, Research
FHI 360, Thailand
Point of View from the EMA
Guido Rasi, MD
Executive Director, European Medicines Agency, European Union
Developing a Scalable and Efficient GLP Training Program
David Brodish, MA
Director, Regulatory and Quality Assurance, RTI International
#140 TRACK 11A – COMPLIANCE TO GOOD CLINICAL
PRACTICE (GCP), GOOD LABORATORY PRACTICE
(GLP), AND QUALITY ASSURANCE (QA)
1:30 PM–3:00 PM
Good Laboratory Practices and Inspection Readiness
Paul Swidersky
President, Quality Associates, Inc.
Related Interest Area(s): GCP, CP, CDM
FORMAT: SESSION
LEVEL: ◆
Room 119a
Quality by Design: Is Your Clinical Trial Fit
for Purpose?
CHAIRPERSON
Room 122b
Postapproval Change Pathways in EU and US:
Challenges and Opportunities for Harmonization
1:30 PM–3:00 PM
Regina Freunscht
Director, Marketing and Communications, Accovion GmbH, Germany
This session facilitates the development of a systematic, prioritized, riskbased approach to quality management of clinical trials that supports the
principles of GCP and complements existing quality practices, requirements,
and standards.
Related Interest Area(s): PC, RA, CP
FORMAT: SESSION
CHAIRPERSON
Christine M. V. Moore, PhD
Acting Director, Office of New Drug Quality Assessment, CDER, FDA
This session will discuss the pathways, similarities, and differences for
submitting postapproval changes to an approved Marketing Authorization
to the EMA and a supplement to an approved NDA/ANDA to the USA.
Speakers from FDA, EMA, and industry will provide a forward-looking view
on current challenges of postapproval changes and on potential opportunities for expansion of risk and science based approaches.
Examples of System Break Down In Clinical Trials: Could "Quality by
Design" Have Saved the Day?
Jean Mulinde, MD
Medical Officer, Office of Scientific Investigations, CDER, FDA
Quality Risk Management (QRM): Bringing a Data-driven Decision
Methodology to GCP and Pharmacovigilance
Peter Schiemann, PhD
Managing Partner, Widler & Schiemann, Switzerland
FDA Point of View
Is Quality By Design (QbD) Really Possible? What Does It Mean? Key
Success Factors to Integrate QbD Principle into QMS
James Huang, PhD
Associate Director, Forest Research Institute
Industry Point of View
Moheb M. Nasr, PhD, MS
Vice President, Regulatory CMC Strategy, GlaxoSmithKline
EMA Point of View
Emer Cooke, MBA
(Acting) Head of International and European Cooperation, European
Medicines Agency, European Union
#141 TRACK 11B – COMPLIANCE TO GOOD CLINICAL
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): RD, PETD, QAQC
LEVEL: ●
FORMAT: SYMPOSIUM
#143 TRACK 13 – HEALTH ECONOMICS AND OUTCOMES
(HEO)/COMPARATIVE EFFECTIVENESS RESEARCH
(CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA)
Room 115c
Good Laboratory Practice (GLP): Design and
Inspection Readiness
1:30 PM–3:00 PM
CHAIRPERSON
Related Interest Area(s): CP, CR
FORMAT: FORUM
LEVEL: ■
Room 107ab
Demystifying Approaches to the Design and
Analysis of Observational Studies of Comparative
Effectiveness
David Brodish, MA
Director, Regulatory and Quality Assurance, RTI International
This symposium reviews the different types of regulations and standards for
the design of laboratory services for both research and health care delivery.
These include GLP, GCLP, ISO 15189, ISO 17025 and others. The basics of
each standard are highlighted showing key considerations for human and
laboratory animal research. A scalable training program is described, that
CHAIRPERSON
Nancy Dreyer, PhD, MPH, FISPE
Senior Vice President, Scientific Affairs, Outcome
45
Monday, June 25
Three speakers from the industry/CRO setting who have successfully
integrated epidemiology into their product development programs will
describe this integration from a structural and functional viewpoint, as
well as share best practices for leveraging epidemiologic talent. The session includes a description of a typical "day in the life" of an industry- or
CRO-located epidemiologist.
Observational research is becoming increasingly important for comparative
effectiveness research (CER). An overview of epidemiologic methods for
design and analysis of observational CER will be presented, along with
quality guides from US and Europe.
Analytic Issues in Comparative Effectiveness Studies
Robert J. Glynn, PhD
Professor of Medicine (Biostatistics), Harvard Medical School and
Harvard School of Public Health
The Pharmacoepidemiologist: Supporting Drug Safety Assessment
Throughout the Life Cycle
Denise M. Oleske, PhD
Director, Global Surveillance & Pharmacoepidemiology, Abbott
Laboratories
Design Issues in Nonexperimental Comparative Effectiveness Studies
Til Stürmer, MD, MPH
Professor, Epidemiology; Director, UNC-GSK CEPPH, University of North
Carolina School of Public Health
Epidemiologists in Industry: Stakeholders and Value Added to Drug
Development
Michael Irizarry, MD, MPH
Worldwide Epidemiology, GlaxoSmithKline
ENCePP and Quality Standards for European Observational Research
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
EMA Risk Management Development and Scientific Lead, European
A Day In the Life of a CRO Epidemiologist
Margaret S. Richards, PhD, MPH
Executive Director, Epidemiology and Health Outcomes, PPD
PHARMACOVIGILANCE
1:30 PM–3:00 PM
THINKING
Related Interest Area(s): CR, MC, AP
LEVEL: ●
FORMAT: FORUM
CME and Nursing
Room 121ab
AE Reporting in the Era of Web 2.0: The Challenges
of Having a Two-Way Conversation
1:30 PM–3:00 PM
Room 113a
Extrapolation to Estimate Treatment Effects in
Subgroups of Special Interest
CHAIRPERSON
CHAIRPERSON
This session will focus on the specific types of social media currently being
used by pharmaceutical companies with discussion on their successes
and challenges. In addition, discussions on AE identification and collection while emphasizing the need for practices and guidance on the use of
social media.
The independent demonstration of treatment effects in subgroups of
special interest such as the pediatric population may not be feasible
because of limited resources and patient populations. However, if there
is prior knowledge available that suggest that efficacy and/or safety may
be at least partly extrapolated from other populations that have already
been investigated, there may be less need for independent evidence in the
subgroup. To safeguard for the possibility that the extrapolation paradigm
does not hold, in general, subgroup validation studies will be required. The
problems of statistical inference in such settings will be discussed from a
regulatory and industry perspective.
Embracing and Incorporating New Technology (eg. Social media,
iPad) into a Modern Pharmacovigilance System
Gregory J. Fiore, MD
President, SSI Strategy
Safety and Social Media: Returning the Intention to Report: Adding
the Human Factor Back to High Tech
Michael A. Ibara, PharmD
Head of Safety Innovation, Pfizer Inc
Assessment Strategies for Clinical Trials of Populations of Special
Interest: The FDA Perspective
Sue-Jane Wang, PhD, MA
Adaptive Design and Pharmacogenomics, CDER, FDA
PHARMACOVIGILANCE
1:30 PM–3:00 PM
Related Interest Area(s): CP, RA
FORMAT: FORUM
CME and Nursing
LEVEL: ■
Issues in the Justification of Extrapolation for Inference on Medicines
for Small Populations
Frank Bretz, PhD
Global Head of Statistical Methodology, Novartis Pharma AG, Switzerland
Related Interest Area(s): CR, PM, ST
FORMAT: SESSION
LEVEL: ●
CME and Nursing
Room 118a
Epidemiologists in Industry and in CROs: Penultimate
Generalists and Utterly Indispensible Scientists
Panelists
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic
Products, Health Canada
CHAIRPERSON
Margaret S. Richards, PhD, MPH
Executive Director, Epidemiology and Health Outcomes, PPD
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER, FDA
46
Monday, June 25
1:30 PM–3:00 PM
LEVEL: ●
Related Interest Area(s): CR, BT, RA
FORMAT: FORUM
1:30 PM–3:00 PM
LEVEL: ■
FORMAT: SESSION
Room 117
My Big Break: Women At the Top in the
Biotechnology Sector
Room 111ab
Challenges of Orphan Drugs in the US, EU, and
Japan
CHAIRPERSON
CHAIRPERSON
C. Latham Mitchell, MD
Managing Principal, Erudita Biotechnical LLC
Noriaki Murao, MS
Representative, Merz Pharmacuticals GmbH, Japan
This forum will highlight women who have truly "arrived" as top executives in the biotechnology space, and let you in on how they got to where
they are today. Pointers, pitfalls, and the prescriptions for your success will
be addressed.
This session addresses the current status and forthcoming activities related
to orphan drugs in the US, EU, and Japan. Orphan drug development is
obviously essential in these regions, and the provisions in place on drugs
including rare diseases are often passed over. We will also address the
unique market situation of orphan drugs in the US and development and
commercialization strategies of orphan drugs in each region.
Leslie Williams, MBA, RN
Director, Founder, President, and Chief Executive Officer, ImmusanT
Orphan Diseases in Adults and Children: Scientific and Regulatory
Challenges in Europe and Worldwide
Klaus Rose, MD, MS
Chief Executive Officer, Klausrose Consulting, Switzerland
Carole Sable, MD
Vice President Project and Pipeline Leader, Merck & Co., Inc.
Yvonne Greenstreet, MD
Senior Vice President, Medicines Development Group, Pfizer Inc
FDA Perspective
Gayatri R. Rao, JD, MD
Acting Director, Office of Orphan Products Development, Office of the
Commissioner, FDA
#148 TRACK 17 – GLOBAL REGULATORY
NEW TIME: 3:30 PM–5:00 PM LEVEL: ■
Related Interest Area(s): RA, CP
FORMAT: FORUM
Asia Perspective
European Town Hall: Part 2 of 2 – Interacting With
the European System
CHAIRPERSON
#150 TRACK 22B – WHITE PAPER SHOWCASE
Christa Wirthumer-Hoche, PhD
Deputy Head, Austrian Medicinal and Medical Device Agency (AGES), Austria
Related Interest Area(s): CR, RA, SP
NEW TIME: 10:00 AM–11:30 AM LEVEL: ●
FORMAT: SESSION
Part 1 of this forum will take place on Monday, June 25 at 10:00am.
Free Agency is Here: Exploring Workforce
Impact on Clinical Outsourcing
MOVED
TO Town
3:30 Hall
PM
route. This second part of the
European
offers insights on the
SEE PAGE 53
different initiatives and entry points to facilitate regulatory procedures and
scientific dialogue from early development to post-marketing authorization
stages. The forum offers the opportunity to interact directly with a panel of
staff from the European Medicines Agency and European national agencies.
CHAIRPERSON
Alan Edwards
Vice President, Americas Product Group, Science, Kelly Services, Inc.
In the past decade clinical trials have become increasingly costly and
more therapeutically specific, both yielding new challenges in the global
MOVEDAdditionally,
TO 10:00 AM
coordination of these programs.
the need for global popuSEE PAGE 40
lation engagement, combined with increasing regulatory requirements,
has stretched the capability of current business models, particularly
as it pertains to efficient management of a workforce to achieve your
company's strategic initiatives.
Xavier De Cuyper
Chief Executive Officer, Federal Agency For Medicines and Health
Products (FAMHP), Belgium
Brought to you by Kelly Services, Inc.
staff member.
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and
Decentralise, BfArM, Germany
Mark Lanfear
Global Practices Leader, Clinical Operations, Kelly Services, Inc.
European Union
3:00 PM–3:30 PM
REFRESHMENT BREAK
Exhibit Hall
47
Monday, June 25
#148 SEE PAGE 53
in a systematic, holistic, and analytically sound manner to enable portfolio
decision-making in the context of an organization's business and strategic
goals. Specifically, while portfolio selection across much of the pharma
and biotech industry has been traditionally achieved through one form or
another of project ranking and selection, the prescribed framework focuses
on portfolio optimization in the context of the organization's constrained
budgetary and human resources.
3:30 PM–5:00 PM
Room 109ab
Related Interest Area(s): CR, IS, PM
LEVEL: ■
FORMAT: FORUM
CME and Nursing
A Day in the Life of a Clinical Research Site: What’s
Getting in the Way?
CHAIRPERSON
Anne-Marie Baughn, MSN, RN
Director, Business Development, RxTrials, Inc.
Facilitators
David Richard Reggi, MA
Principal, DRR Pharmaceutical R&D Solutions, LLC
Results from a 2011 nationwide survey will be presented. Sites will report on
the factors they face on a daily basis that compete for their time, resources,
and productivity. The "not so well understood" issues that sites face will
be highlighted.
Alka Shrikhande
Senior Therapeutic Area Advisor, BioXcel
Suzanne Wentz
President, Odyssey Research
STRATEGIC PLANNING
Kerri M. Mallory, MSc
Site Development Manager, GlaxoSmithKline Biologicals
3:30 PM–5:00 PM
Katherine Tranotti, BSN, MBA, RN
Vice President, Clinical Operations, ICON Clinical Research
LEVEL: ■
Related Interest Area(s): CR, FI, EC
FORMAT: FORUM
CHAIRPERSON
Jim L. Vandergriff, II
Pharmaceutical Project Management, Eli Lilly and Company
Room 108a
ePatient Recruitment, Study Sites, and the Digital
Divide
During project execution, a project manager must be diligent to monitor
the progress of the work and be ready to intervene when risks or challenges threaten to derail the project. Good monitor and control processes
and related tools are essential enablers. This session will present case
studies that exemplify how project managers can achieve project goals of
delivering on time, on budget, and providing the full scope of work while
maintaining quality output.
CHAIRPERSON
Elizabeth A. Moench
President and Chief Executive Officer, MediciGlobal
ePatient recruitment has come too fast for many trial sites. Their expertise
has not kept pace with online marketing. Sites face a dilemma; return on
investment of local media budgets is diminishing as eClinical consumers
seek clinical trials online.
Leveraging Critical Chain Methodology for Successful Project
Execution: A Story of Two Case Studies
Jim L. Vandergriff, II
Pharmaceutical Project Management, Eli Lilly and Company
Setting Sites Up for Success in the New Digital Environment
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services, PRA
International
Why Have a Critical Path Schedule, We All Know What’s Important?
Timothy M. Phelan, PhD
Senior Group Leader, Merck & Co., Inc.
Keys to the Successful Application of Portfolio Risk Management in
Kristin Mauri, MBA
Director, Clinical Services, ClearTrial, LLC
STRATEGIC PLANNING
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): PM, CR, SP
FORMAT: SESSION
Room 103c
Keys to Successful Project Execution: Innovative
Approaches to Critical Chain, Critical Path, and
Risk Management
3:30 PM–5:00 PM
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, IT
FORMAT: WORKSHOP
Room 121c
PMI PDUs
Enhancing Decision Making and Maximizing
Portfolio Value Creation Using a Novel Portfolio
Management Framework
#155 TRACK 03A – INNOVATIVE PARTNERING MODELS AND
CHAIRPERSON
3:30 PM–5:00 PM
Richard Bayney, PhD, MBA
President and Founder, Project & Portfolio Value Creation
Room 111ab
Pharma R&D in Asia: Opportunities, Models, and
Challenges
CREOPM™ is a novel portfolio management framework that improves
decision-making under risk and uncertainty. To complement this framework,
a portfolio management capability maturity model assessment is proposed.
This workshop will enable participants to approach portfolio management
LEVEL: ■
PMI PDUs
Related Interest Area(s): OS, RD, CR
FORMAT: SYMPOSIUM
CHAIRPERSON
Frank Ulrich Flöther, DrSc, PharmD
President, Dr. Flöther Consulting, Switzerland
48
Monday, June 25
The center of the global pharmaceutical industry is shifting. Part of that
shift is also the outsourcing of pharma R&D to Asia by various means and
models. This symposium will highlight that strategic move in general but
also discuss a clinical CRO alliance model and, furthermore, zoom into the
Chinese clinical CRO business.
QT "derisking," mandated for all drugs, has become simpler and inexpensive
to confidently achieve in early-phase clinical studies. Learn how to acquire
continuous ECG data with small N and analyze by methods translated from
preclinical to human.
The Use of Positive Controls in Derisking
William Wheeler, MD
Independent Cardiovascular Consultant, Wheeler Biopharm Consulting, LLC
Outsourcing to/Partnering with Asian Companies: Benefits,
Opportunities, and Risks for Western Pharmacos
Frank Ulrich Flöther, DrSc, PharmD
President, Dr. Flöther Consulting, Switzerland
Translating Preclinical Repolarization Data to Guide Clinical Studies
Gary Gintant, PhD, MA
Research Fellow, Abbott Laboratories
CRO Alliance in Asia
Young Jack Lee, PhD
President, LSK Global PS, Republic of Korea
QT Derisking with Continuous ECG Data Analysis
Development
The Challenges of Chinese CROs’ Business
Jack Xu, MD
Senior Vice President, Shanghai Clinical Research Center (SCRC), China
COMMUNICATIONS
#156 TRACK 03B – INNOVATIVE PARTNERING MODELS AND
3:30 PM–5:00 PM
LEVEL: ■
3:30 PM–5:00 PM
Related Interest Area(s): OS, RD, RA
FORMAT: SESSION
Room 108b
Communicating Drug Safety Information Using
Social Media: FDA and Industry Perspectives
Room 105ab
Pre-competitive Public Private Partnerships: The
Changing Model of Pharmaceutical R&D
CHAIRPERSON
CHAIRPERSON
Catherine Yu Chew, PharmD
Acting Deputy Director, Division of Drug Information, CDER, FDA
Ruth Tal-Singer, PhD
Vice President, Clinical Discovery, Respiratory Therapy Area Unit,
GlaxoSmithKline
FDA relays the latest drug safety information through drug safety communications which are disseminated using social media tools. This session
provides FDA and industry perspectives on the development, communication, dissemination, and impact of drug safety communications.
This session will focus on an emerging approach to R&D using specific
examples for public-private partnerships in chronic obstructive pulmonary
disease and oncology. The role of biomarkers and patient-reported outcomes in research and development of new medicines, the current regulatory environment for biomarker and endpoint qualification, and key success
factors for public-private partnerships will be discussed.
Communicating Drug Safety Information: FDA Perspective
Catherine Yu Chew, PharmD
Acting Deputy Director, Division of Drug Information, CDER, FDA
Communicating Drug Safety Information: FDA Perspective
Gregory Busse, PhD
Senior Writer/Editor, Team Lead for Drug Safety Communications,
CDER, FDA
Partnering to Qualify Biomarkers for Chronic Obstructive Pulmonary
Disease (COPD)
Ruth Tal-Singer, PhD
Vice President, Clinical Discovery, Respiratory Therapy Area Unit,
GlaxoSmithKline
Communicating Drug Safety Information: Industry Perspective
Sue E. James
Vice President, Global Regulatory and Quality, Consumer Healthcare,
GlaxoSmithKline
PRO Consortia: A Success Story
Nancy Kline Leidy, PhD
Senior Vice President, Scientific Affairs, United BioSource Corporation
Public/Private Partnerships in Conducting Observational Studies:
The Experience of the Italian Cancer Drugs Register
Luca De Nigro, MS
Coordinator, Drugs Monitoring Register, Italian Medicines Agency
(AIFA), Italy
CLINICAL RESEARCH
3:30 PM–5:00 PM
Related Interest Area(s): EC, SE, IT
LEVEL: ■
FORMAT: SESSION
Room 103b
PRO Measurement in Clinical Trials: Need for
Education and Training
3:30 PM–5:00 PM
Related Interest Area(s): MC, CP, RA
FORMAT: SESSION
LEVEL: ■
CHAIRPERSON
Related Interest Area(s): PC, NC, CP
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Josephine M. Norquist, MS
PRO Specialist, Merck Sharp & Dohme Corp.
Room 124
Drug QT Derisking: Changes in When and How
This session will present two examples of initiatives in pharmaceutical
companies for PRO education and training as well as present the current
initiatives being developed through the PRO Consortium, a partnership
between pharmaceutical companies and the FDA to develop qualified, PRO
endpoints to support product labeling claims.
CHAIRPERSON
William Wheeler, MD
Independent Cardiovascular Consultant, Wheeler Biopharm Consulting, LLC
49
Monday, June 25
How to ‘DeVISE’ Clinical Trial Endpoints to Meet Regulatory
Requirements for Labeling Claims
Josephine M. Norquist, MS
PRO Specialist, Merck Sharp & Dohme Corp.
PDUFA V: Charting the Course
Andrew Emmett
Managing Director, Science and Regulatory Affairs, The Biotechnology
Industry Organization (BIO)
Initiative for PRO Education and Training
Clarice (Risa) P. Hayes, PhD
Research Advisor, Global Health Outcomes, Eli Lilly and Company
FDA Roadmap: How Key Changes Will Impact the Review of
Applications
Beth Duvall
Associate Director for Regulatory Affairs, Office of New Drugs, CDER, FDA
FDA Point of View
Laurie Burke, MPH, RPh
Director for Study Endpoints and Labeling, Office of New Drugs,
CDER, FDA
Navigating the New Course: Industry Perspective
Robert J. Meyer, MD
Head, Global Regulatory Strategy, Policy and Safety, Merck, Sharp &
Dohme Corp.
CLINICAL RESEARCH
3:30 PM–5:00 PM
Related Interest Area(s): EC, IT, CDM
LEVEL: ■
FORMAT: SESSION
3:30 PM–5:00 PM
LEVEL: ■
FORMAT: SESSION
Electronic Health Records (EHR)/Electronic Data
Capture (EDC) Opportunities
Room 115a
Streamlining of Clinical Trial Review Process in
Asian Pacific Region
CHAIRPERSON
CHAIRPERSON
Vice President, Quality and Regulatory Affairs, Medidata Solutions
Worldwide
Chih-Hwa Wallace Lin, PhD
Director, Division of Resource Development, Center for Drug Evaluation,
Taiwan
In an electronic health care world, drug developers have the opportunity to
leverage the advantages of EHRs for patients, physicians, regulators, and
the developers themselves. This session will discuss various use cases to
explore the use of data from EHRs in accelerating a variety of processes
associated with clinical trials and drug development across typical health
care settings and research processes.
With global development, Asian regulatory agencies are streamlining the
clinical trial process. Taiwan is adapting the Clinical Trial Notification (CTN)
and Clinical Trial Exemption (CTX). system. Korea and Japan have enhanced
the review of the clinical trial. This session will discuss revolutionary measures and impacts.
Room 103a
Integrated Review Office: Experience on an Innovative Review Team
on Clinical Trials in Taiwan
Director General, Food and Drug Administration, Department of Health,
Taiwan
Semantic Search Technology to Mine Electronic Patient Records for
Clinical Research and Personalized Medicine
Joerg F. Kraenzlein, DrMed, PhD
Director Clinical Research, CSC, Germany
Good Review Practice in Asia Pacific
Neil McAuslane, PhD, MSc
Director, Centre For Innovation In Regulatory Science (CIRS), UK
Seamlessly Moving Patients Utilizing EHRs: Case Study at Walter
Reed Army Medical Center
Harry J. Fisher
President, Health ResearchTx LLC
Challenges and Opportunity For Clinical Trials in the Asia Pacific
From a Pharmaceutical Industry Perspective
Shun Jin, MBA
Associate Director, Takeda Global Research & Development Center, Inc.,
Singapore
Exploring the Use of Data from EHR's in Accelerating a Variety of
Processes Associated with Clinical Trials and Drug Development
Steven P. Schwartz
Senior Vice President, Corporate Business Development, Allscripts
3:30 PM–5:00 PM
LEVEL: ■
FORMAT: SESSION
3:30 PM–5:00 PM
Related Interest Area(s): CR, RA, MC
FORMAT: FORUM
CME and Nursing
LEVEL: ■
Room 119b
Vaccines: FDA and Japan Perspectives
Room 113c
Analysis and Impact of PDUFA V: How the Changes
Will Affect the Work of Regulatory Affairs
Professionals
CHAIRPERSON
CHAIRPERSON
Florence Houn, MD, MPH, FACP
Co-chair, FDAAA International Network, FDA Alumni Association
Janet Jenkins-Showalter
Director, Regulatory Policy, Strategy and Intelligence, Genentech, A Member
of the Roche Group
Perspectives from FDA CBER vaccines office on vaccine development and
external communications policies, along with industry views on regulation
and development from Japan will be presented.
The PDUFA V agreement will become effective on October 1, 2012.
Prescription drug regulatory professionals need to understand the rationale
for changes, their impact, and how to use the new framework toward
achieving more first cycle approvals.
Japan Update on Vaccine Developments and Regulations
Yoshikata Furuya, MSc
Manager, Regulatory and Vaccine Policy, Health Policy and Access, MSD
K.K., Japan
50
Monday, June 25
#166 TRACK 11A – COMPLIANCE TO GOOD CLINICAL
CBER Vaccine Regulatory Update
Sara Gagneten, PhD
Regulatory Scientist, Office of Vaccines, CBER, FDA
FDA's Office of Vaccines Research and Review Considerations on
Vaccine Communication
Maureen Hess, MPH
Health Science Advisor, Office of Vaccines Research and Review,
CBER, FDA
3:30 PM–5:00 PM
Room 119a
Conducting Clinical Trials in Developing Countries:
Challenges in Meeting Good Clinical Practice (GCP)
Compliance
CHAIRPERSON
3:30 PM–5:00 PM
LEVEL: ◆
Sherri A. Hubby
Director, US Quality Assurance, Premier Research Group Ltd
FORMAT: SESSION
With the challenges in recruitment and placing more global studies in
developing countries, regulatory agencies have raised concerns over ethical
and data quality standards. Cultural diversity, variability in ethical review,
difficulty in recruiting investigators with GCP experience and different
regulatory standards in non ICH countries constitute major challenges to
pharmaceutical industries and marketing authorization agencies related to
compliance with GCP and ethical standards. This symposium covers local laws,
specific customs within developing regions such as Asia, Africa, and South
America and examples of effective methods for dealing with and managing
the trial requirements, managing risks and providing solutions for developing local partners and cooperative efforts with foreign regulators and IRBs.
Room 118c
Discussion with Former Center for Devices and
Radiological Health (CDRH) Management
CHAIRPERSON
Daniel G. Schultz, MD
Senior Vice President, Medical Devices & Combination Products, Greenleaf
Health, LLC
Join this moderated panel discussion with former CDRH Directors and
Management. The session will focus on the evolving face of medical devices,
the interface between drugs and devices, new challenges and opportunities,
and the changing regulatory landscape.
Conducting Clinical Trials in Developing Countries: A Comparison
Between Expectations of the FDA, EMA, and ANMAT Regulators
Sherri A. Hubby
Director, US Quality Assurance, Premier Research Group Ltd.
David W. Feigal, Jr., MD, MPH
Partner, NDA Partners, LLC
Donna-Bea Tillman, PhD
Senior Consultant, Biologics Consulting Group
Fostering Quality Assurance in Ethical Review in Asia: Towards
Harmonization of IRB Procedures with GCP Standards
Ock-Joo Kim, MD, PhD, MS
Director, Center for Human Subject Protection, Seoul National
University Hospital, Republic of Korea
Timothy Alan Ulatowski, MS
Director, Medical Devices, Becker & Associates Consulting, Inc.
An Exploratory Study to Identify Challenges to Full Good Clinical
Practice (GCP) Compliance in Sub-Saharan Africa
Ghiorghis Belai, MS
Senior Clinical Research Manager, FHI 360
3:30 PM–5:30 PM
LEVEL: ●
Pharmacy
LEVEL: ■
FORMAT: SYMPOSIUM
CME and Nursing
Related Interest Area(s): CR, IS
FORMAT: FORUM
ANMAT Perspective
Augustina Bisio
Room 116
CHAIRPERSON
Mark C. Hegarty, JD
Partner/Attorney, Shook, Hardy & Bacon L.L.P.
#167 TRACK 11B – COMPLIANCE TO GOOD CLINICAL
This forum will address a wide range of regulatory and legal issues governing modern clinical research. Using a well known game show format,
experts will compete to show their knowledge of the elements of informed
consent, IRB requirements, FDA regulations, the history of clinical investigations, and other key topics.
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): CR, CP, QAQC
FORMAT: SESSION
Room 115c
Building Quality into Clinical Trials: Regulatory
Perspectives and Practical Considerations
Jeffrey N. Gibbs, JD
Director, Hyman Phelps & McNamara, PC
CHAIRPERSON
John M. Isidor, JD
Senior Director and Co-Founder, Schulman Associates IRB, Inc.
Winifred Ann Meeker-O’Connell, MS
Acting Associate Director, Risk Science, Intelligence, and Prioritization, Office
of Scientific Investigations, Office of Compliance, CDER, FDA
Current models for clinical trial oversight have become outmoded in a
global, complex environment. This session describes recent efforts to foster
new models that employ risk-based approaches and that build quality into
clinical trials.
51
Monday, June 25
other data streams. This forum will address potential applications of quality
assessment tools to the evaluation of pharmacoepidemiologic safety studies and the development of a tool to assess observational CER studies. A
panel will discuss these issues and their implications.
EMA Perspective: Quality Risk Management in Clinical Development
Fergus Sweeney, PhD
Epidemiologic Drug Safety Data: The Need for Quality Assessment
Tarek A. Hammad, MD, PhD, MS
Deputy Division Director, Division of Epidemiology-I, CDER, FDA
FDA CDER Perspective: Building Quality into Trial Design, Conduct,
and Reporting
Acting Associate Director, Risk Science, Intelligence, and Prioritization,
Office of Scientific Investigations, Office of Compliance, CDER, FDA
Review of Quality of Evidence Assessment Tools for the Evaluation
of Observational Pharmacoepidemiologic Safety Studies
George Neyarapally
Interdisciplinary Scientist, Office of Surveillance and Epidemiology,
CDER, FDA
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): CM, MF, RA
FORMAT: SESSION
GRACE Checklist: A Validated Tool for Rating the Quality of
Observational Studies of Comparative Effectiveness
Nancy Dreyer, PhD, MPH, FISPE
Senior Vice President, Scientific Affairs, Outcome
Room 122b
Opportunities for Global Harmonization of
Inspection Paradigm
Panelist
Alexander M. Walker
Principal, World Health Information Science Consultants (WHISCON)
CHAIRPERSON
Stephan Karl Roenninger, DrSc
Head, External Collaboration Europe/Japan/CEMA, F. Hoffmann-La Roche
Ltd., Switzerland
Industry has experienced a large increase in the number of Good
Manufacturing Practice (GMP) related inspections of their manufacturing
sites around the world. It is acknowledged that this is partly due to the
increasing global complexity of pharmaceutical supply chains and consequent dissemination of regulatory oversight to multiple worldwide inspections. This session will discuss how emerging regulatory requirements put
additional hurdles on resource management and facilitate a more effective
use and oversight of companies’ efficiencies, and enforcement policies as
driven by pharmaceutical quality systems in inspectorates and industry.
PHARMACOVIGILANCE
Related Interest Area(s): DM, CR, CDM
3:30 PM–5:00 PM
Room 121ab
Electronic Health Records (EHR) and Medication
Safety and Adherence
CHAIRPERSON
Edward Fotsch, MD
Chief Executive Officer, PDR Network
Regulatory Perspective: Quality Systems in Inspectorates Support
Harmonized Inspection Management
Ian Jackson
Operations Manager, Medicines and Healthcare products Regulatory
Agency (MHRA), UK
Recent, rapid advances in Health Information Technology (HIT), the everwidening deployment of new electronic systems, as well as new FDA goals
for EHRs now make it possible to both generate positive health outcomes
at the point of care and identify important drug-related safety issues that
may have previously gone undetected. Medication adherence can now be
pursued using communication to both provider and patient using EHRs.
Adverse Drug Event (ADE) reporting tools can now operate both independently and as components within existing EHR/EMR systems, and the
data that they capture and generate can be combined with new tools and
approaches to data mapping, safety analysis, and interoperability. With
these new advancements comes the potential to improve the validation and
correlation of safety signal data. As provider workflow evolves from a fragmented traditional approach into one that is more integrated and cohesive,
EHR-centric systems are emerging as important pharmacovigilance tools
which may prove crucial to the advancement of ADE reporting, early warning systems and safety signal detection.
Perspective From Industry: Considerations on Inspection Practices
Head, External Collaboration Europe/Japan/CEMA, F. Hoffmann-La
Roche Ltd., Switzerland
A Regulator’s Perspective: The Value of PIC/S Membership
Branch Chief, International Compliance Branch, Division of
Manufacturing and Product Quality, Office of Compliance, CDER, FDA
3:30 PM–5:00 PM
Room 107ab
LEVEL: ■
FORMAT: SYMPOSIUM
Using GIS to Identify Safety Signals in FDA’s Adverse Event
Reporting System (AERS) Database
Joseph Tonning, MD, MPH, RPh
Medical Officer, Office of Surveillance and Epidemiology, CDER, FDA
Related Interest Area(s): CP, CDM
LEVEL: ■
FORMAT: FORUM
Application of Quality of Evidence Assessment
Tools to the Evaluation of Observational
Pharmacoepidemiologic Studies
Electronic Health Records: The Powerful New Platform for Product,
Risk Management and Safety Communications
Edward Fotsch, MD
Chief Executive Officer, PDR Network
CHAIRPERSON
George Neyarapally
Interdisciplinary Scientist, Office of Surveillance and Epidemiology, CDER, FDA
ICD-9-CM to MedDRA® Mapping: How Well Do the Two Terminologies
Correlate
Anna C. Zhao-Wong, MD
Medical Officer, MedDRA® MSSO
The assessment of the benefits and risks associated with drug exposure
take into consideration data from pharmacoepidemiologic studies and from
52
Monday, June 25
Electronic Health Records: The Powerful New Platform for Product,
Risk Management and Safety Communication
Linda J. Scarazzini, MD
Director of Division of Pharmacovigilance I, CDER, FDA
PHARMACOVIGILANCE
3:30 PM–5:00 PM
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): CR, RA, PM
FORMAT: SYMPOSIUM
Room 117
Building International Competence in Drug
Development Teams
Related Interest Area(s): CR, RD, RA
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Room 118a
Use It Early and Often: Epidemiology's Many Roles
in Clinical Development and Beyond
CHAIRPERSON
Mary S. Murray, MBA
Learning Manager, Bristol-Myers Squibb Company
CHAIRPERSON
This symposium introduces learning tools and concepts employed to develop
the capabilities needed among a global clinical staff through different drug
development stages. Special emphasis is placed on training requirements and
strategies to advance drug development in Japan and the BRICT countries
(Brazil, Russia, India, China, Turkey). Presenters offer case studies, lessons
learned experiences and a job aid to help participants design and develop
their own training programs for clinical staff and regulatory scientists.
Nataliya Volkova, PhD, MPH
Director, Epidemiology, Pfizer Inc
Seasoned epidemiologists use a framework of investigational, filing and
post-marketing activities to bring to life the role of epidemiology in product support. Real world examples from actual projects are the basis for
this session.
Uses of Epidemiology in Clinical Drug Development
Nancy A. Brandenburg, PhD, MPH
Senior Director, PV and Epidemiology, Celgene Corporation
New Approaches for Pharmaceutical Medicine Training
Joao Massud, MD
CEO, Trials Consulting, Brazil
The Role of Epidemiologists in the Peri-approval Period: REMS,
RMPs and Beyond
Nataliya Volkova, PhD, MPH
Director, Epidemiology, Pfizer Inc
Fostering Global Competence for Regulatory Scientists in an Age of
Simultaneous Global Drug Development
Junichi Nishino, MPharm, RPh
Group Manager, Process Improvement and Excellence Group, Drug
Regulatory Affairs, Novartis Pharma K.K., Japan
Epidemiologic Studies as Part of Risk Management Strategies for
Marketed Products
Catherine Sigler, DVM, MPH
Senior Epidemiologist, United BioSource Corporation
Clinical Staff Training in Eastern Europe
Andrei Kravchenko, MD, PhD
Head of Representative Office in Ukraine, Harrison Clinical Research
Deutschland GmbH, Ukraine
Preparing for Clinical Development BRICT by BRICT
Mary S. Murray, MBA
Learning Manager, Bristol-Myers Squibb Company
THINKING
3:30 PM–5:00 PM
LEVEL: ■
CME and Nursing
FORMAT: SESSION
Room 113a
Rates and Weights: Quantifying Clinical Impact
and Judgment in Benefit-risk Assessment
NEW TIME: 3:30 PM–5:00 PM LEVEL: ■
FORMAT: FORUM
Room 120bc
European Town Hall: Part 2 of 2 – Interacting With
the European System
CHAIRPERSON
Bennett Levitan, MD, PhD
Director, Epidemiology, Janssen Research & Development, LLC
CHAIRPERSON
Complex benefit-risk assessments require quantifying tradeoffs between
multiple benefits and risks. This session examines an assessment for
triptans in migraine and compares two different weighting methods that
incorporate patient or clinical judgment.
Deputy Head, Austrian Medicinal and Medical Device Agency (AGES), Austria
Part 1 of this forum will take place on Monday, June 25 at 10:00am.
Preference Weight Approach to Triptans Benefit-risk Assessment
Brett Hauber, PhD
Senior Economist, RTI International
route. This second part of the European Town Hall offers insights on the
different initiatives and entry points to facilitate regulatory procedures and
scientific dialogue from early development to post-marketing authorization
stages. The forum offers the opportunity to interact directly with a panel of
staff from the European Medicines Agency and European national agencies.
Multicriteria Decision Analysis Approach to Triptans Benefit-risk
Assessment
Lawrence Phillips, PhD
Visiting Professor of Decision Sciences, Department of Management,
London School of Economics, UK
Panelists
Telba Irony, PhD
Chief, General Surgical Devices Branch, CDRH, FDA
53
Monday, June 25
Xavier De Cuyper
Chief Executive Officer, Federal Agency For Medicines and Health
Products (FAMHP), Belgium
5:00 PM
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and
Decentralise, BfArM, Germany
5:00 PM–6:30 PM
LEVEL: ●
Related Interest Area(s): RA, PPLCC
FORMAT: SESSION
Room 113b
An Update on EMA, FDA, and PMDA International
Activities
CHAIRPERSON
Toshiyoshi Tominaga, PhD
Office Director, Office of International Programs, Pharmaceuticals and
Medical Devices Agency (PMDA), Japan
EMA, FDA and Japan's MHLW/PMDA have been each implementing unique
global strategies, while cooperating with each other. This session discusses
their international activities and accomplishments.
EMA Update
Emer Cooke, MBA
FDA Update
Mary Lou Valdez
Associate Commissioner for International Programs, Office of the
Commissioner, FDA
PMDA Update
Yuki Ando
Office of International Programs, Pharmaceuticals and Medical Devices
Agency (PMDA), Japan
#175 TRACK 22 – WHITE PAPER SHOWCASE
3:30 PM–5:00 PM
WELCOME RECEPTION
Exhibit Hall
European Union
3:30 PM–5:00 PM
END OF MONDAY
OFFERINGS
Related Interest Area(s): RA, MW, DM
FORMAT: SESSION
LEVEL: ●
Room 125
Raising the Bar for Regulatory Submission
Document Quality: A Collaborative, Transitional
Approach
CHAIRPERSON
Mauricha F. Marcussen, MBA
Program Manager, Life Sciences, Agano Solutions
This White Paper Showcase explores the needs of regulatory affairs
operations and the medical writing community in regards to the delivery
of comprehensive, quality content, and uncovers the document-related
risks associated with the submission process.
Brought to you by Microsystems.
staff member.
54
NOTES
55
NOTES
56
Tuesday, June 26
STRATEGIC PLANNING
TUESDAY, JUNE 26
Registration Hours:
7:00 AM–4:30 PM
Broad Street Lobby
7:00 AM–4:30 PM
8:00 AM–9:30 AM
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, SP
FORMAT: SESSION
Room 113b
Project and Program Management Competency
Models for the (Bio) Pharmaceutical Industry
Schedule:
CHAIRPERSON
Richard J. Heaslip, PhD
President and Founder, Programmatic Sciences
8:00–9:30 AM
9:00 AM–3:30 PM
9:30–10:00 AM
Coffee Break
Exhibit Hall
This session will explore approaches to the development of competency
models that are specifically tailored to organizational needs. It will include a
discussion of best practices and case studies from companies with different
management philosophies.
10:00–11:30 AM
11:00 AM–1:30 PM
Professional Poster Session
Exhibit Hall D
11:30 AM–1:30 PM
Exhibit Hall
1:30–3:00 PM
7:15–8:00 AM
1:30–3:30 PM
3:00–3:30 PM
Refreshment Break
Exhibit Hall
3:30–4:30 PM
Critical Considerations in the Development of Project Management
Competency Models in the Pharmaceutical Industry (and the
Dangers of Getting It Wrong!)
Development of a Project Management/Project Leadership
Competency Model
Leigh Shultz, PhD, PMP
Senior Group Leader, Merck & Co., Inc.
Sponsor versus CRO Project Management: Are Different Competency
Models Needed?
Paul R. Bunch, PhD
Vice President, Global Project Management, Covance, Inc.
STRATEGIC PLANNING
8:00 AM–9:30 AM
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, FI, SP
FORMAT: SESSION
8:00 AM–9:30 AM
Room 103c
Optimizing Drug Development Portfolios: An
Integrated Approach
LEVEL: ■
Related Interest Area(s): OS, SP, CR
FORMAT: FORUM
Room 105ab
PMI PDUs
The New Reality — Strategic Partnerships under
Scrutiny: Are They Working, and How Long Will It
Take to Ensure Success?
CHAIRPERSON
Zoran Antonijevic, MSc
Senior Director, Center for Statistics in Drug Development, Innovations,
Quintiles
CHAIRPERSON
Patricia Leuchten
CEO and President, The Avoca Group Inc.
This session will demonstrate an integrated, value-driven approach as
a basis for pharmaceutical portfolio planning and management. In this
approach, decisions are defined such that the expected value of pharmaceutical portfolios is maximized.
This forum will explore CROs’ and sponsors’ assessment of the realities
of implementing new outsourcing strategies. Data from the 2012 State of
Clinical Outsourcing research will be shared. A panel of industry experts will
provide their perspective.
Value-based Drug Development
Zoran Antonijevic, MSc
Senior Director, Center for Statistics in Drug Development, Innovations,
Quintiles
Paul D. Spreen
Senior Vice President and Global Head, Customer Solutions
Management Group, Quintiles
Peter A. DiBiaso, MHA
Senior Director, Head, Clinical Business Operations, Vertex
Pharmaceuticals
Challenges of Portfolio Management and Optimization
Charles Persinger, MBA
Senior Research Scientist, Decision Sciences, Eli Lilly and Company
Chris Davis, RPh
Director, External Sourcing, Eli Lilly and Company
Maximizing Portfolio Value under Budget Constraints
Nitin R. Patel, PhD, MBA
Chairman and Chief Technology Officer, Cytel, Inc.
57
Tuesday, June 26
8:00 AM–9:30 AM
CLINICAL RESEARCH
Related Interest Area(s): BT, NC, PC
FORMAT: SYMPOSIUM
LEVEL: ■
CME and Nursing
8:00 AM–9:30 AM
Room 124
Novel Imaging Techniques Symposium
Related Interest Area(s): SE, RA, CEHTAEbM
FORMAT: SESSION
LEVEL: ■
Room 103a
Defining Study Endpoints in 2012: The Journey
Continues
CHAIRPERSON
Director, Clinical Pharmacology, Duke University Medical Center
CHAIRPERSON
John M. Weiler, MD, MBA
President, CompleWare Corporation
Developing techniques to better understand the adsorption, distribution,
metabolism and excretion (ADME) of novel investigational compounds
presents unique challenges for the clinical research facility, academic or
nonacademic, as well as the pharmaceutical industry. In this symposium,
three differing approaches to examining the use of radio-labeled compounds will be explored. These different aspects of imaging technology
are highly desirable tools in understanding drug mechanisms of action and
deposition within either tumor spaces or other sites of action.
This session will bring together life sciences professionals including regulatory authorities to discuss the taxonomy used for study endpoints and the
importance of identifying what is meaningful to be measured before focusing on how to measure it.
FDA Point of View
CDER, FDA
Quantitative PET Imaging with F-18 FDG and F-18 FLT: Using Imaging
Biomarkers in Multicenter Clinical Trials
Jeffrey T. Yap, PhD
Senior Diagnostic Physicist, Dana-Farber Cancer Institute
Panelist
John H. Powers, III, MD, FACP
Senior Medical Scientist, Collaborative Clinical Research Branch, NIAID,
SAIC/National Institutes of Health
Utilization of USP<797> to Enable On-site Compounding of IV 14C
Microtracer or IV 14C/3H Macrotracer Dose for Human AME Study
Robert George Kochan, PhD
US Clinical Pharmacology Radiation Safety Officer, Covance Clinical
Development Services
CLINICAL RESEARCH
Related Interest Area(s): CDM, EC, IT
The Use of Fluorescence Correlation Spectroscopy (FCS) as an
Alternative Biomarker Detection Technique
Aamir Shahzad, MD, DrMed
Secretary General and Director of Administration, International Society
For Translational Medicine (ISTM), Austria
8:00 AM–9:30 AM
LEVEL: ■
FORMAT: SYMPOSIUM
Room 103b
Evolving eContent Design and Exchange for
Clinical Studies
CHAIRPERSON
George Waidell
Vice President, Life Sciences Practice, Intralinks, Inc.
COMMUNICATIONS
8:00 AM–9:30 AM
As the prevalence of technology during all stages of the development
process continues to expand, the importance of leveraging both existing
and new technology and moving beyond basic implementation into true
business value and efficiencies is critical. This symposium will explore three
different areas of applications of both design and content sharing that
apply current technologies with the opportunity to extend and drive further
process integration.
Related Interest Area(s): MC, AP, CDM
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Room 108b
Medical Contributions to Promotional Tactics
CHAIRPERSON
David B. Clemow, PhD
Clinical Research Scientist, Eli Lilly and Company
Moving Safety Reporting to the Cloud: How to Leverage SaaS-based
Solutions for Safety Reporting
George Waidell
Vice President, Life Sciences Practice, Intralinks, Inc.
This session will describe the who, what, why, and how of the contributions of medical personnel to US product promotions, and medical's role in
checking clinical data to ensure medical/scientific accuracy, label-alignment,
and clinical relevance.
Medical Contribution to Promotion: Who, What, and Why
The Integration of Medical Imaging into eTMF Systems for Endpoint
Collection
James DeSanti
President and CEO, PharmaVigilant
Medical Contribution to Promotion: Development, Net Impression,
and Avoiding Enforcement Letters
Janet L. "Lucy" Rose, MBA
President, Lucy Rose and Associates, LLC
The Re-use of define.xml as Metadata for CRF Design
Philippe Verplancke, PhD
Managing Director, XClinical GmbH, Germany
Medical Contribution to Promotion: How
Kristin Fox Goettner, PharmD
Associate Director, Medical Information, Janssen Scientific Affairs, LLC
58
Tuesday, June 26
8:00 AM–9:30 AM
Related Interest Area(s): RA, CEHTAEbM, SP
LEVEL: ■
FORMAT: FORUM
8:00 AM–9:30 AM
Room Terrace 4
Meta-collaborations: A Call to Action
FORMAT: SESSION
LEVEL: ◆
Room 113c
CHAIRPERSON
Freda Lewis-Hall, MD
Chief Medical Officer and Senior Vice President, Pfizer Inc
CHAIRPERSON
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney, The Kulkarni Law Firm
What are the barriers that are keeping ideas from turning into action, and
how can these barriers be broken to develop new models for innovation
and collaboration? Senior-level thought leaders will address these questions
and discuss how industry, academia, government, and patients, through
meta-collaborations, can take drug discovery to the next level by creating
opportunities for moving forward and coming up with solutions faster.
This session will provide a broad-based review of the various laws and
regulations that impact clinical trials. This discussion will focus primarily
on issues including the Foreign Corrupt Practices Act, False Claims Act,
anti-kickback laws, determination of fair market value, and HIPAA. There
will also be a discussion on the non-FDA governmental organizations that
may get involved in clinical trial compliance including HHS and the US
Attorney’s Office.
Government Initiatives to Stimulate Innovation in Medical Health
Sciences
Stephen P. Spielberg, MD, PhD
Deputy Commissioner, Medical Products and Tobacco, Office of the
Commissioner, FDA
Legal and Compliance Issues in Clinical Trials
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney, The Kulkarni Law Firm
Panelists
Margaret A. Anderson, MS
Executive Director, FasterCures
Panelists
Catherine Dabney Clemons, JD, MBA
Corporate Counsel, Daiichi Sankyo Inc.
Kathy L. Hudson
Deputy Director for Science, Outreach, and Policy, National Institutes
of Health
Stacey Smith, JD
Attorney, Department of Justice, US Attorney’s Office
8:00 AM–9:30 AM
Related Interest Area(s): DM, SUBS, RA
LEVEL: ■
FORMAT: SESSION
8:00 AM–9:30 AM
LEVEL: ●
Related Interest Area(s): QAQC
FORMAT: WORKSHOP
Room 123
Quality Risk Management Workshop
Room 120bc
Electronic Drug Registration and Listing: FDA and
Industry
CHAIRPERSON
Fritz Erni, DrSc
Consultant, Switzerland
CHAIRPERSON
Leyla Rahjou-Esfandiary, PharmD
Pharmacist, Office of Compliance, CDER, FDA
This interactive workshop will give a brief overview of simple quality risk
management (QRM) tools. In small groups, participants will work with common QRM tools such as Process Maps, Fishbone Diagrams and Failure Mode
Effects Analysis (FMEA) to determine product critical quality attributes and
critical process steps for a simple manufacturing process.
This session will provide a regulatory overview of drug establishment
registration and drug listing requirements, FDA’s National Drug Code (NDC)
Directory, the Drug Establishments Current Registration Site (DECRS), some
recent updates, and also industry’s perspective; challenges and benefits.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
FDA Point of View
Lieutenant Soo Jin Park, PharmD
Pharmacist, Office of Compliance, CDER, FDA
Moderators
Patricia L. Cowall-Hanover, PhD, MBA, RAC
Regulatory Consultant, Eli Lilly and Company
Celia N. Cruz, PhD
Chemist, Office of New Drug Quality Assurance, Office of
Pharmaceutical Science, CDER, FDA
59
Tuesday, June 26
8:00 AM–9:30 AM
LEVEL: ■
THINKING
8:00 AM–9:30 AM
Related Interest Area(s): CR, RA, RD
FORMAT: SESSION
Room 113a
NDA/BLA Statistical Review and the CDISC ADaM
Data Standards
Room 107ab
Recent Advancement of HTA and Its Impact
on Health Care Reform and Product Life Cycle
Management in the Asian Pacific Region
CHAIRPERSON
Stephen E. Wilson, USPHS, DrPH
Director, Division of Biometrics III, CDER, FDA
CHAIRPERSON
Director, Division of Resource Development, Center for Drug Evaluation, Taiwan
This forum will describe the receipt and statistical review of analysis files
based on the ADaM standards at the Center for Drug Evaluation and
Research. The panel will discuss problems and potential improvements.
Systems for health technology assessments (HTAs) have been established
in Taiwan and Korea. China is considering establishing a system similar to
NICE. The session will discuss and compare HTA practices in the Pacific
region, including Canada and the US.
ADaM Review from a CDER Statistical Reviewer’s Perspective
Behrang Vali, MS
Regulatory Reviewer, Division of Biometrics 3, Office of Translational
Sciences/Office of Biostatistics, CDER, FDA
Mapping the Regulatory, HTA, and Payer Processes: A Key to Multistakeholder Understanding
Lawrence E. Liberti, MS, RPh, RAC
Executive Director, Centre for Innovation in Regulatory Science (CIRS)
CDISC ADaM Implementation: Present Impact and Future Directions
Michael Nessly, MS
Biostatistics Group Leader, Shire Specialty Pharmaceuticals
HTA in Asia Pacific: Trends in Use of Health Economics and Managed
Entry Agreements
Abdulkadir Keskinaslan
Pricing Director Region AMAC and China, Novartis Pharma AG,
Switzerland
Standardized ADaM Data Sets for Submissions: A Case Study with
Patient Reported Outcomes (PRO)
James R. Johnson, PhD, MS
Director, Head Global Statistical Programming, UCB BioSciences Inc.
Pharmacoeconomics and Outcomes Research of Innovative Vaccines
Leona E. Markson
Executive Director, Global Health Outcomes, Merck & Co., Inc.
9:30 AM–10:00 AM
COFFEE BREAK
Exhibit Hall
#213 TRACK 14 – CLINICAL SAFETY AND
PHARMACOVIGILANCE
8:00 AM–9:30 AM
Related Interest Area(s): CDM
FORMAT: FORUM
LEVEL: ■
Related Interest Area(s): GCP, CR, RA
LEVEL: ■
FORMAT: SESSION
CME and Nursing
10:00 AM–11:30 AM
Related Interest Area(s): CP, EC, RA
FORMAT: SYMPOSIUM
LEVEL: ■
CME and Nursing
Data Monitoring Committee (DMC): When You
Need One and When You Don’t!
Room 108a
Understanding Risk-based Monitoring: Is It Art,
Science, or Both?
CHAIRPERSON
CHAIRPERSON
Barton L. Cobert, MD, AHIP, FACP
President, BLCMD Associates, LLC
Kathleen Findlen
Director, Clinical Operations, Collegium Pharmaceutical
This session describes what a Data Monitoring Committee (DMC) is, how it
is constituted, when it is needed, its duties, responsibilities, charter, actions,
interim analyses and consequences of its actions. Ethical issues, complexities, examples and problems will be discussed.
FDA has recently issued two important and related draft guidance documents covering electronic source and risk-based monitoring. FDA now
clearly expects sponsors to take better advantage of electronic data capture (EDC) technology by implementing a targeted, risk-based approach to
monitoring data remotely. Targeted source document verification (SDV) can
be a highly effective and low-cost method of implementing an innovative
monitoring strategy where 100% monitoring of site data is costly and not
needed. Yet, in light of these potential cost savings, targeted SDV is still
more of a frequent discussion topic rather than a reality. This symposium
will provide perspectives on how this guidance could change the day-today relationships of sites/sponsors/monitors.
Room 121ab
Data Monitoring Committee (DMC)
Barton L. Cobert, MD, AHIP, FACP
President, BLCMD Associates, LLC
Operational Issues: Herding the DMC Cats
Art Gertel, MS
Vice President, Strategic Regulatory Consulting, Medical Writing, and
QA, Beardsworth Consulting Group Inc.
Targeted Source Document Verification: The Decision Makers'
Perspective on "To SDV or Not to SDV"
Jennifer Abrams Stier
Senior Director, Product Management, Medidata Solutions Worldwide
Mapping the Charter
Gil Price, MD
President, Drug Safety Solutions
Risk-based Monitoring: Challenges and Opportunities for Field
Monitors and Data Managers
Steve Shevel, MBA
Associate, Waife & Associates Inc.
60
Tuesday, June 26
Changing the Monitor/Site/Sponsor Relationship through Electronic
Source Documents
CEO, Clinical Ink
Site Metrics for Study Start-up
Christine K. Pierre, RN
President, RxTrials, Inc.
STRATEGIC PLANNING
10:00 AM–11:30 AM
Room 111ab
Related Interest Area(s): CR, IT, PM
FORMAT: FORUM
LEVEL: ■
CME and Nursing
10:00 AM–11:30 AM
CHAIRPERSON
CHAIRPERSON
John Z. Sun, PhD, MBA, PMP
Global Program Team Director, Novartis Pharmaceuticals Corporation
Neil Weisman
Executive Vice President and General Manager, Blue Chip Patient Recruitment
Outsourcing and participation in clinical trials in China and other Asian
countries have expanded dramatically in recent years. Many global companies now have ongoing or newly initiated collaboration with their local subsidiaries or selected CRO in the Asia-Pacific region. Along with the apparent
advantages and fast-paced development, the global and local project teams
often face various unforeseen challenges that may result from the cultural
differences leading to misalignment and frustration on both sides. In the
sponsor-CRO collaboration, these variances include different expectations
and project management practices ranging from project planning, risk management, and communication. This session will discuss the key differences
and challenges of project management practice through case studies, and
identify better ways to optimize the project performance internally within
the matrix environment or when collaborating with a CRO.
How can patient recruitment capitalize on the rapid growth of mobile
health technology? This forum will discuss how sponsors, sites and CROs
can improve patient recruitment efforts using mobile technology.
Redesigning the Future of Clinical Trials: A Collaborative Approach
Harnessing the Power of Mobile Technology
Tim Davis
CEO and Co-founder, Exco InTouch, UK
Is Patient Recruitment Ready for Mobile Health Technology?
A Survey Analysis
Neil Weisman
Executive Vice President and General Manager, Blue Chip Patient
Recruitment
Optimizing Project Performance in a Matrix Environment: CRO
Perspective in Asia Context
Jing Ping Yeo, PhD
Director, PAREXEL International, Singapore
How a CRO Is Using Mobile Health Technology
Owen Garrick, MD, MBA
Chief Operating Officer, Bridge Clinical Research
Working with Project Teams from China
Jenny Zhang, MD, MHA
Director, Business Development (USA), ACRP China Chapter President,
Tigermed Consulting Ltd.
LEVEL: ■
Related Interest Area(s): OS, PM
FORMAT: SESSION
Room 113b
Optimizing Performance in Outsourced Projects in
China and Other Asian Countries
The Next Patient Recruitment Frontier: Leveraging
Mobile Health Care Technology (mHealth) to
Recruit Patients for Clinical Trials
10:00 AM–11:30 AM
LEVEL: ●
Related Interest Area(s): CP, IS
FORMAT: SESSION
Oversight for Strategic Outsourcing Projects in China and Asia
Countries: From the Sponsor Perspective
Catherine Lee, MBA, MPharm, MSc
Area Head-Asia, Clinical Trial Support and Compliance, Pfizer Inc, Taiwan
Room 109ab
CME and Nursing
Update on Collaborative Projects of the Clinical
Trials Transformation Initiative (CTTI)
CHAIRPERSON
Jose M. Vega, MD
Vice President, Amgen Global Safety, Amgen Inc.
STRATEGIC PLANNING
This session will present results of three Clinical Trials Transformation
Initiative (CTTI) projects conducted by representatives of FDA, industry,
academia, patients, and others: 1) Premarket Safety Management, 2) Central
IRBs in Multicenter Trials, and 3) Site Metrics for Study Start-up.
10:00 AM–11:30 AM
LEVEL: ■
Related Interest Area(s): FI, PM, CR
FORMAT: SESSION
Room 103c
Improving Protocol Design: Current Industry
Practices and New Approaches
IND Safety Assessment and Communication: Biopharmaceutical
Industry Perspective
Jose M. Vega, MD
Vice President, Amgen Global Safety, Amgen Inc.
CHAIRPERSON
Linda B. Sullivan, MBA
Vice President, Metrics Champion Consortium
IND Safety Assessment and Communication: FDA Perspective
Patrick Archdeacon
Medical Officer, Office of Medical Policy, CDER, FDA
This session will examine current costs and issues associated with poorly
designed protocols and explore new approaches being developed and utilized by organizations to improve protocol design and reduce the incidence
of protocol amendments.
Central IRBs for Multicenter Clinical Trials
Cynthia Hahn
Administrator, Office of Research Compliance, The Feinstein Institute
for Medical Research
61
Tuesday, June 26
Carbamazepine Hypersensitivity. A Case Study of Bioactivation to
B*1502
J. Steven Leeder, PharmD, PhD
Professor of Pediatrics and Pharmacology, Children’s Mercy Hospitals
and Clinics
Quantifying the Impact of Protocol Design Complexity on Drug
Development Cost and Performance
Kenneth A. Getz, MBA
Tufts Center for the Study of Drug Development, Chairman, The Center
for Information and Study on Clinical Research Participation (CISCRP),
Tufts University
Nonclinical Testing of Skin Hypersensitivity in Drug Development
Jessica Whritenour, MS, PhD
Immunotoxicology Center for Emphasis, Drug Safety Research and
Development, Pfizer Inc
Getting It Right the First Time: Utilizing a Protocol Quality
Evaluation Tool to Improve Protocol Design
Vice President, Metrics Champion Consortium
Many Drugs Highly Associated with Stevens Johnson Syndrome
Undergo Biotransformation by CYP2C9 and CYP3A4
Keith K. Burkhart, DrMed
Senior Advisor, Medical Toxicology, Office of New Drugs, CDER, FDA
Structured Study Design Driving Trial Efficiencies
Michelle Marlborough
Director, Product Management, Medidata Solutions Worldwide
10:00 AM–11:30 AM
LEVEL: ●
Room 105ab
PMI PDUs
COMMUNICATIONS
FORMAT: SESSION
10:00 AM–11:30 AM
Room 108b
Related Interest Area(s): MC
FORMAT: FORUM
LEVEL: ■
The Unintended Consequences of Strategic
Partnerships
CHAIRPERSON
Art Gertel, MS
Vice President, Strategic Regulatory Consulting, Medical Writing, and QA,
Beardsworth Consulting Group Inc.
CHAIRPERSON
Michael A. Martorelli, MBA
Director, Fairmount Partners
This forum will consider the increasing number of retractions by scientific
and medical journals, and the potential impact of retracted data that remain
in play. Putative causes, mitigation, and prevention will be discussed.
Sponsors and CROs have entered numerous long-term strategic partnerships. Public CROs have begun to describe some unintended financial consequences of these relationships. This session will help audience members
cope with these problems.
Publish or Perish: The Legacy of Retracted Scientific Literature
Art Gertel, MS
Vice President, Strategic Regulatory Consulting, Medical Writing, and
QA, Beardsworth Consulting Group Inc.
Reviewing Selected Unintended Consequences
Michael A. Martorelli, MBA
Director, Fairmount Partners
The Good, The Bad, and The Ugly: What Retractions Say About
Scientific Transparency
Ivan Oransky, MD
Executive Editor, Reuters Health
A Sponsor's View of Unexpected Partnership Issues
Ian C. Lauf
Outsourcing Manager, Boehringer-Ingelheim
Strategic Outsourcing: The Next Big Model
Michael J. Rosenberg, MD, MPH
President and CEO, Health Decisions Inc.
Correcting the Literature: Mistake or Misconduct
Diane Scott-Lichter, MA
Publisher, American Association For Cancer Research
Improving Drug Development Partnerships
Anthony J. Carita
President, CTB Solutions, Inc.
CLINICAL RESEARCH
10:00 AM–11:30 AM
10:00 AM–11:30 AM
Room 103a
Related Interest Area(s): NC, CP, PC
LEVEL: ◆
FORMAT: SESSION
Related Interest Area(s): EC, SE, CDM
LEVEL: ●
FORMAT: FORUM
CME, Pharmacy, Nursing, and PMI PDUs
Labeling Claims Based on Patient-reported
Outcome Measures: It Takes a Village!
Room 124
Skin-drug Biotransformation: What Testing Should
We Do?
CHAIRPERSON
J. Jason Lundy, PhD
Director, ePRO Consortium, Critical Path Institute
CHAIRPERSON
A pragmatic overview will be provided that delineates the series of activities necessary to properly develop and implement a patient-reported
outcome (PRO) measure in a clinical trial for the purposes of product
approval and labeling. During this interactive forum, a real-world example
will be used to illustrate the considerations and associated resources
that a clinical trial sponsor may face when using a PRO instrument as an
efficacy endpoint.
Keith K. Burkhart, DrMed
Senior Advisor, Medical Toxicology, Office of New Drugs, CDER, FDA
AERS data mining supports the hypothesis that drugs associated with
Stevens Johnson Syndrome (SJS) undergo biotransformation. Reviews of
the role of drug metabolism and SJS and preclinical testing for skin hypersensitivity are provided.
62
Tuesday, June 26
Labeling Claims Based on Patient-reported Outcome Measures
J. Jason Lundy, PhD
Director, ePRO Consortium, Critical Path Institute
Negotiating Pediatric Drug Development With FDA and EMA:
Operational Guidance and Essential Background Information
Klaus Rose, MD, MS
Chief Executive Officer, Klausrose Consulting, Switzerland
FDA Point of View
James P. Stansbury, PhD, MPH
Endpoints Reviewer, Study Endpoints and Labeling Development Staff,
CDER, FDA
FDA Point of View
Lisa L. Mathis, MD
Associate Director, Office of New Drugs, Pediatric and Maternal Health
Staff, CDER, FDA
Sponsor Point of View
Clarice (Risa) P. Hayes, PhD
Research Advisor, Global Health Outcomes, Eli Lilly and Company
Ronald Portman, MD
Group Director, Bristol-Myers Squibb Company
CLINICAL RESEARCH
10:00 AM–11:30 AM
Related Interest Area(s): CDM, IT, RA
LEVEL: ■
FORMAT: SESSION
10:00 AM–11:30 AM
Related Interest Area(s): RA, CP, MF
FORMAT: SESSION
LEVEL: ■
Room 103b
Lessons Learned from FDA-sponsored ARRA
PCOR (American Recovery and Reinvestment
Act Patient Centered Outcomes Research) Data
Standardization Efforts
Room 120bc
CHAIRPERSON
This session will focus on characterizing the current issues surrounding
shortages of medically necessary drug products. Speakers will focus on
history, repetitive patterns of problems, and our path forward. This will
include present initiatives underway and strategies under consideration for
effectively dealing with, and mitigating existing drug shortage situations,
and for preventing new drug shortages from developing. The respective
roles of both industry and the FDA in addressing drug shortage situations
will be discussed.
CHAIRPERSON
Sandra L. Kweder
Deputy Director, Office of New Drugs, CDER, FDA
Crystal Allard, RAC
Consumer Safety Officer, Office of Chief Scientist, Office of the
Commissioner, FDA
FDA would like to share their experiences in standardization of data at
each center. Each speaker will discuss the most valuable lessons they have
learned during the conversion process including outstanding technical and
policy issues.
Amy Malla, MT, PMP
Consumer Safety Officer, Office of the Director, CBER, FDA
Emily T. Thakur, RPh
Senior Program Management Officer, Drug Shortage Program, Office of
New Drugs, CDER, FDA
Helena Sviglin, MPH
Regulatory Information Specialist, Office of Translational Sciences,
CDER, FDA
Laina Bush, MBA
Associate Deputy Assistant Secretary, Planning and Evaluation, HHS
Ted Peterson, MS
Division of Biostatistics, Orise Fellow, CDRH, FDA
Jonathan Kafer
Vice President, Sales and Marketing, Teva Pharmaceuticals
Lilliam Rosario, PhD
Associate Director, Office of the Chief Scientist, Office of the
Commissioner, FDA
Related Interest Area(s): CmbP, RA
10:00 AM–11:30 AM
Room 118c
10:00 AM–11:30 AM
Room 119b
LEVEL: ●
FORMAT: SYMPOSIUM
Related Interest Area(s): CR, PPLCC
LEVEL: ■
FORMAT: SESSION
CME and Nursing
CHAIRPERSON
Stephen Paul Holcroft
Vice President, Regulatory Affairs, Johnson & Johnson Vision Care, Inc.
Pediatric Development in the US: Implementation
of 2007 PREA and BPCA Against a Backdrop of the
EU Pediatric Legislation
This symposium will discuss the shifting borderlines between medicines and
other product both a continuing concern and an opportunity for all companies, and the role of clinical trials in establishing the best treatment of care
using both drugs and devices. We will also identify regulatory issues related
to safety, performance and effectiveness.
CHAIRPERSON
Chin Koerner, MS
Executive Director, Regulatory Policy, Novartis Pharmaceuticals Corporation
The Frontier Edges Between Medicines, Medical Devices, Cosmetics,
Biocides and Other Health Care Regulated Products
With the passage of the US and EU pediatric legislation, companies are
challenged to meet the requirements of FDA and EMA. Differing timelines,
processes and standards require well managed interactions with health
authorities to achieve consensus.
Drug Device Combination Products: Regulatory Path to Approval in
Global Perspective Including New Requirements on Use Safety
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Tuesday, June 26
Two-arm Double Randomized Clinical Trial Using Drugs and Devices
Sunita Prem Ahir, PhD, MSc, RAC
Regulatory Affairs Manager, D-Target, a Premier Research Company,
Switzerland
10:00 AM–11:30 AM
Room 119a
Preparing for CMC Meetings with the FDA
10:00 AM–11:30 AM
LEVEL: ●
CHAIRPERSON
Michael Folkendt, MS
Associate Director for Regulatory Affairs, Office of New Drug Quality
Assurance, Office of Pharmaceutical Science, CDER, FDA
Related Interest Area(s): CP, RA
FORMAT: SESSION
Meetings with the FDA are an important part of the drug development process. This session will provide insight on how and when to best meet with
the FDA, how to successfully request and plan for a CMC meeting for CDER
NDAs, BLAs, and supplements.
Room 113c
Pharmacy
CHAIRPERSON
Gizzy Klink, JD
Senior Associate, NautaDutilh N.V., Netherlands
CMC Meetings With the FDA: Tips to a Successful Meeting
Jeannie C. David, MS
Regulatory Health Project Manager, Office of New Drug Quality
Assurance, Office of Pharmaceutical Science, CDER, FDA
In this session, an overview will be given of both legislation and case law
with respect to product liability on both sides of the Atlantic. The session
will provide hands-on information for advice to clients and will discuss current case law.
Considerations for Planning a CMC Meeting with the FDA
Toni-Marie Nearing
Senior Director, Global Regulatory Affairs, Quintiles
Managing Product Liability Risks in the EU
Gizzy Klink, JD
Senior Associate, NautaDutilh N.V., Netherlands
CMC Meetings with the FDA: Timing, Preparation, and Execution
Antoinette Paone, MBA, MSc
Senior Director, Global CMC Regulatory Affairs Strategy, Vertex
Pharmaceuticals Incorporated
What Life Science Companies Need to Know About Product Liability
But Are Afraid to Ask: Focus on Research Risks
Becki Kanjirathinkal, MS
Risk Control Consulting Director, CNA Healthpro
Understanding and Minimizing Product Liability Risk for Prescription
Drugs Marketed in the United States
Linda Pissott Reig, JD
Shareholder, Buchanan Ingersoll & Rooney PC
10:00 AM–11:30 AM
Room 107ab
10:00 AM–11:30 AM
LEVEL: ◆
Related Interest Area(s): CMC, RA, CR
FORMAT: SESSION
CME and Nursing
LEVEL: ●
Related Interest Area(s): PR, CR, RA
LEVEL: ●
FORMAT: FORUM
The Effects of NICE Technology Assessments on
Prescribing and Cost-sharing Behavior in the US
CHAIRPERSON
Related Interest Area(s): RA, CR, IS
FORMAT: SESSION
John J. Doyle, DrPH, MPH
Room 115c
Misconduct and Management of Serious or
Continued Noncompliance: What Are the
Differences and Similarities?
As US health care increasingly looks towards proven clinical effectiveness for
reimbursement decisions, it has been hypothesized that health technology
assessments (HTAs) published by NICE would influence drug prescribing
and patient cost-sharing expenditures in the US according to the nature
of the published guidance. HTAs are multidisciplinary policy analyses that
examine the medical, economic, social, and ethical implications of the
incremental value, diffusion and use of a medical technology in health care.
The assessment function entails the process of collecting, evaluating, and
systematically reviewing all available evidence for the technology under
consideration. As a result, inherent elements of the technology appraisal
process include differential analysis and implementation by different payers
around the world and varied adoption of recommendations by all stakeholders including health care providers, patients and advocacy groups,
and payers.
CHAIRPERSON
Deborah A. Waltz, MS
Senior Director, Scientific Operations Quality, Pfizer Inc
This session will provide regulatory perspective on new enforcement directives which place greater emphasis on accountability for compliance for all
parties involved in the research enterprise.
What Does FDA Really Enforce and How? A Comprehensive Research,
Review, and Trending Analysis of FDA GxP Enforcement Practice
James Huang, PhD
Associate Director, Forest Research Institute
The Effects of NICE Health Technology Assessments on Prescribing
in the US: Overview
John J. Doyle, DrPH, MPH
Panelist
Constance Cullity, MD, MPH
Branch Chief, Division of Scientific Investigations, Office of Compliance,
CDER, FDA
How the Same Licensing Data Are Differently Evaluated by Payers
Pietro Folino Gallo, DrMed
Head of European Assessment Unit, Italian Medicines Agency (AIFA), Italy
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Tuesday, June 26
The Evolution of Health Technology Assessments in the US
Joseph DiCesare, MPH
Vice President, Global Health Economics and Outcomes Research,
Novartis Pharmaceuticals Corporation
Pharmacovigilance in Japan: Regulator Perspective
Junko Sato, PhD
Director for Risk Management, Office of Safety II, Pharmaceuticals and
Indicators of Health Technology Adoption in the US
Josephine A. Sollano
Head, Global Health Economics and Outcomes Research, Pfizer Inc
Trend of Pharmacovigilance Practices in Japan
Yorozu Tabata, MA
Manager, PRTM Japan
PHARMACOVIGILANCE
10:00 AM–11:30 AM
THINKING
Related Interest Area(s): CR, CDM, EC
LEVEL: ■
FORMAT: SESSION
CME and Nursing
10:00 AM–11:30 AM
Related Interest Area(s): CR, RA
LEVEL: ■
FORMAT: SESSION
Room 121ab
Comparison of National-level Drug Utilization
Patterns from Large Commercial Health Care
Databases with Mini-Sentinel
Room 113a
FDA Draft Guidance on Multiple Endpoints in
Clinical Trials
CHAIRPERSON
Bruce Binkowitz, PhD, MSc
Senior Director, Clinical Biostatistics, Merck Research Laboratories
CHAIRPERSON
Laura Governale, PharmD
Deputy Director for Drug Use, Office of Surveillance and Epidemiology, FDA
Clinical trials evaluate effects of one or more treatments typically on
multiple primary and secondary endpoints. This raises multiplicity issues if
there are alternative paths in the trial for winning for treatment effects. In
addition, clinical trials frequently evaluate treatment effects on subpopulations, perform interim analyses and use adaptive designs which add yet
another dimension of multiplicity. All these increase the risk of making false
conclusions about the treatment effects, if not handled properly. FDA, upon
recognizing the importance of multiplicity, has recently developed draft
guidance on this topic. This session will address issues of multiple comparison and the new draft guidance.
This session will present and discuss information generated by the MiniSentinel Summary Tables and Modular Programs compared with similar
analyses using nationally representative commercial drug utilization databases for selected drug products.
FDA Perspective — Overview of Mini-Sentinel
Marsha E. Reichman, PhD
Senior Advisor, Office of Surveillance and Epidemiology, CDER, FDA
Comparison of Commercial Drug Utilization Data to Mini-Sentinel Data
Laura Governale, PharmD
Deputy Director, Division of Epidemiology II, CDER, FDA
FDA Perspective
Kathleen S. Fritsch, PhD
Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Advancing Safety Surveillance through Collaboration
Head of Clinical Analytics, Quintiles
An Industry Perspective
Frank Bretz, PhD
Global Head of Statistical Methodology, Novartis Pharma AG,
Switzerland
PHARMACOVIGILANCE
10:00 AM–11:30 AM
Room 118a
Panelist
Robert J. Temple
LEVEL: ■
FORMAT: SYMPOSIUM
CME and Nursing
Pharmacovigilance in Japan and Risk Management
Plans
#235 TRACK 16A – PROFESSIONAL DEVELOPMENT
CHAIRPERSON
10:00 AM–11:30 AM
Stewart Geary, MD
Vice President, Eisai Co., Ltd., Japan
Room 121c
Advanced Presentation Skills
This symposium will provide an update on the latest developments in pharmacovigilance in Japan with speakers from the regulatory authority and the
pharmaceutical industry based in Japan. Discussions will provide both an
overall description of the current system of drug safety regulation, as well
as recently implemented changes and the prospects for further developments in drug safety regulation in Japan.
LEVEL: ■
Related Interest Area(s): PETD
FORMAT: WORKSHOP
CHAIRPERSON
Lauren Edelstein Henry, MEd
Principal Operational Specialist, Janssen Pharmaceutical Companies of
Johnson & Johnson
This workshop will delve deeper into presentation skills. Topics include how
to handle a hostile/overly inquisitive audience, presenting via web/teleconference, multicultural presenting, presenting scientific data and more.
The Japan Pharmaceutical Affairs Law
Professor, Regulatory Sciences, Faculty of Pharmacy, Keio University,
Japan
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
65
Tuesday, June 26
So You Think You Want to Work Remotely?
Betty R. Kuhnert, PhD, MBA
President, BRKuhnert LLC
Facilitator
Matthew C. Henry, PhD
Investigator, GlaxoSmithKline
Room 117
10:00 AM–11:30 AM
Associate Commissioner for International Programs, Office of the
Commissioner, FDA
Related Interest Area(s): CR, RD, CP
Join members of various Latin American agencies as they discuss individual
country-specific regulatory framework and strategies related to the field
of bioethics. Given the rapid growth of the clinical trials industry in the
region, the Bioethics Committees topic has become more prominent as an
area of research, public discussion and debate. It is no longer a subject that
can be confined to science, medicine, and academia. As such, regulatory
bodies across the region are facing the need of responding with an optimal
framework that serves the whole industry while complying with the ethical
aspect of the case. This forum has been designed as a frank, open dialogue
among regulators to share their experiences in creating and implementing
their sets of regulations covering Bioethics Committees (BECs).”
LEVEL: ●
FORMAT: WORKSHOP
Room 123
CHAIRPERSON
Jesús Rivera
Senior Learning Manager, Bristol-Myers Squibb Company
Illness unfolds as a complex and interconnected set of narratives. This workshop will introduce participants to the skills and habits of reflective writing
and listening in order to better recognize, receive, absorb, interpret, and
honor stories of illness towards the goal of achieving narrative competence.
Clinical practice fortified by the knowledge of what to do with stories can
result in better patient care and health outcomes.
Bioethics Committees Regulation.
Luis Eduardo Johnson Rojas, Sr., MPH
Manager, Office of Clinical Trials and Bioethics, Instituto de Salud
Publica de Chile (ISPCH), Chile
be recorded.
Panelists
New Molecules and Research Director, COFEPRIS, Mexico
Augustina Bisio
10:00 AM–11:30 AM
LEVEL: ■
FORMAT: FORUM
CHAIRPERSON
#236 TRACK 16B – PROFESSIONAL DEVELOPMENT
10:00 AM–11:30 AM
LEVEL: ●
FORMAT: FORUM
Manager, Research and Clinical Trials, ANVISA Brazil
Room 116
International Regulatory Cooperation: A Canadian
Perspective
CHAIRPERSON
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products,
Health Canada
10:00 AM–11:30 AM
Related Interest Area(s): CR, RA, CDM
LEVEL: ●
Format: SESSION
Room 125
Value of Actigraphy in Clinical Trials
Health Canada has engaged in various forms of international cooperation
over the years, from information sharing to harmonization and mutual
recognition. This forum will look at current trends, drivers and opportunities
for more effective cooperation and sort through the growing number of
terms used to describe such activities. Specific examples will be presented
as a basis for discussion, including the exploration of an international model
for worksharing in the area of generic drug review.
CHAIRPERSON
Barry T. Peterson, PhD
Senior Manager, Clinical Affairs, Phillips Respironics
This White Paper Showcase will describe the current applications of
actigraphy in clinical trials, important considerations when including
actigraphy in the protocol, regulatory aspects, and current research that
can increase the value of actigraphy in the near future.
A New Era in International Regulatory Cooperation: What You Need
to Know
Mike D. Ward
Manager, International Programs Division, Health Canada
Brought to you by Phillps Respironics.
Attendee badges scanned for this White Paper Showcase will be shared with the Company
staff member.
The Formation of a New International Initiative on the Review of
Generic Drugs: A Regulator’s Perspective
Andrew M. Adams
Director, Bureau of Pharmaceutical Sciences, Health Canada
Jeremiah J. Trudeau, PhD
Director, Psychometrics and Outcomes, Analgesic Solutions
Susan M. Vallow, MA, MBA
Director, Patient Reported Outcomes, Janssen Global Services, LLC
The Formation of a New International Initiative on the Review of
Generic Drugs: An Industry Perspective
Nicholas Cappuccino, PhD, MBA
CEO, Pharmaceutical Intellectual Resource Services, LLC
John P. Breeden
Senior Manager Clinical Operations, Philips Respironics
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Tuesday, June 26
11:30 AM–1:30 PM
LUNCHEON
Exhibit Hall
1:30 PM–3:00 PM
12:00 PM–12:45 PM
Room 108a
Investigator Budgets’ Impact on Patient Enrollment
and Retention: How to Improve Sponsor/CRO/Site
Selection Processes
LEVEL: ●
Aptiv® Solutions Innovation Theater
Related Interest Area(s): RD, IT
SPECIA
SESSIO L
N
See the map located on the back of the
Exhibitors tab for location.
ADDPLAN PE- Innovative Software for
Population Enrichment Designs in Adaptive
Clinical Trials
CHAIRPERSON
Daniel M. Ulrey, MBA
President and CEO, Midwest Clinical Support, Inc.
Study budgets and site identification and selection processes continue to
result in study timelines being extended and a significant loss of experienced investigators. Senior executives from industry will discuss how
identification and selection processes can be improved as well as how to
achieve real fair market value in site study budgets and payment terms.
These methods and processes continue to cause a dramatic reduction in
the number of GCP-qualified US-based investigators and have dramatically extended study timelines and added significant cost to Pharma,
resulting in severe Pharma employee reductions and cost shifting of
R&D expense to CROs. It remains to be seen if this strategy will result in
increased productivity.
There is a growing interest among regulators and sponsors in using
personalized medicine approaches that allow for targeted patients
to receive maximum benefit from the correct dose of a specific drug.
Population enrichment designs offer a specific adaptive trial methodology to study the effect of experimental treatments in various subpopulations of patients under investigation. ADDPLAN PE is the first
and only software available for the design and simulation of population
enrichment trials.
Sites Tackle the Financial Challenges of Conducting Clinical Research
Joan A. Chambers
Chief Operating Officer, CenterWatch, Inc.
1:30 PM–3:00 PM
Related Interest Area(s): CR, PR, RD
FORMAT: SESSION
CME, Nursing and PMI PDUs
LEVEL: ■
Related Interest Area(s): CR, IS, QAQC
LEVEL: ■
FORMAT: FORUM
CME and Nursing
Planning for and Executing a Successful Study Start
Kellie Malloy
Vice President & General Manager, Pain & Inflammatory Disease/CV and
Metabolic, Pharmanet/i3
Room 109ab
Effective and Efficient Monitoring as a Component
of Quality Assurance in the Conduct of Clinical Trials
Does Site Reimbursement Support Patient Recruitment
and Retention?
Debby Brown
Senior Vice President, Clinical Operations, ICON Clinical Research
CHAIRPERSON
Joan Harley, BSN, RN
Training Consultant and eLearning Developer, Training Extension, Division of
Pastor Consulting, Inc.
The forum will present data collected from the Clinical Trials Transformation
Initiative (CTTI) survey on clinical trial monitoring and auditing practices
used by organizations to address regulatory requirements, provide a rationale for the re-evaluation of these practices, and summarize new industry
trends in the areas of monitoring and auditing of clinical trials.
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): CR, IS, CDM
FORMAT: WORKSHOP
Room 123
Sponsors and CROs: Don’t Be Misled by Your Site
Performance Data
Training, Site Selection, and Human Subject Protection: Factors to
Consider When Developing a Monitoring Plan
Cynthia Kleppinger, MD
Senior Medical Officer, Office of Scientific Investigations, CDER, FDA
CHAIRPERSON
Adam Chasse, MHA
Vice President, Corporate Development, RxTrials, Inc.
Source Data Verification: Targeting Critical Elements
Cynthia R. Zacharias
Executive Director, Clinical Operations-Americas, Celgene Corporation
More sponsors/CROs are using historical performance data for site selection
and partnering decisions. However, many companies fall into decision traps
because they collect the wrong data and/or interpret them inappropriately.
This workshop will address the development of metrics, as well as discuss
their interpretation and the common decision traps that project managers
fall into when considering predictive value of metrics.
Range of Practices for the Monitoring of Clinical Trials
Jennifer K. Giangrande, PharmD
Senior Regional Manager, Hoffmann-La Roche Inc.
Panelist
Jules T. Mitchel, PhD, MBA
President, Target Health Inc.
be recorded.
Facilitator
Executive Director, Elite Research Network
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Tuesday, June 26
STRATEGIC PLANNING
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): PM, RD, CR
FORMAT: SYMPOSIUM
1:30 PM–3:00 PM
Room 113b
Planning Your Drug’s Development Life Cycle
Gregg Schneider
Director, R&D Financial Management, Otsuka Pharmaceutical
CHAIRPERSON
Ed Silverman
Editor, Pharmalot, UBM
This symposium will focus on issues surrounding a drug's development life
cycle, the use of simulation modeling to enhance development strategy
and portfolio decision making, as well as new approaches in portfolio risk
assessment and mitigation.
Hear from top executives as they share their vision for the future of pharmaceutical development. What will it look like in five years, and how do
we get there? What trends do we see? Have we seen the end of risk- and
equity-sharing models in partnering? What are the pressures of private
versus public ownership?
Planning Your Drug’s Development Life Cycle: A Primer
Scott A. Simmons, MA
Consultant, Pharmaceutical Project Management, Eli Lilly and Company
Submit your questions to the panel to [email protected],
Subject: collaborative partnerships
Using Simulation Modeling to Support Development Strategy and
Portfolio Management
Badri Rengarajan, DrMed
Medical Director, Archimedes
Overview
Douglas J. Peddicord, PhD
Executive Director, Association of Clinical Research Organizations
Panelists
Jeffrey P. McMullen
President and CEO, PharmaNet/i3, an inVentiv Health Company
Strategic Portfolio Planning for Global Drug Development:
Approaches, Techniques, and Tools
Vladimir Shnaydman, PhD
President, ORBee Consulting
William J. Sharbaugh, MA, MSc
Chief Operating Officer, PPD
STRATEGIC PLANNING
LEVEL: ■
Related Interest Area(s): OS, CR, SP
FORMAT: FORUM
Room 121ab
Collaborative Partnerships in Drug Development:
An Executive Roundtable Discussion
CHAIRPERSON
1:30 PM–3:00 PM
LEVEL: ◆
PMI PDUs
Josef von Rickenbach, MBA
Chairman and CEO, PAREXEL International
Related Interest Area(s): PM, SP, CR
FORMAT: SESSION
Paula Brown Stafford, MPH
President, Clinical Development, Quintiles
Room 103c
Leaping the Valley of Death: Keys to
Successfully Going from the Lab to the Clinic for
Pharmaceutical Products
John Watson
Chief Commercial Officer, Corporate Senior Vice President, and
President of Strategic Partnering, Covance Inc.
CHAIRPERSON
Michael A. Swit, JD
Special Counsel, Duane Morris, LLP
Going from the lab to the clinic is the first huge leap in drug development.
This session will explore how to ensure that the jump over the "valley of
death" is smooth and avoids the sponsor falling into an abyss of bad decisions and poor results.
1:30 PM–3:00 PM
Room 124
Related Interest Area(s): NC, PC, CP
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Product Candidate to Proof-of-concept: An
Integrated Approach to Accelerate Programs
Unique Advantages of an Integrated Vertical in the Drug Discovery
and Development Process
Zia Haque, MA
Senior Director, Clinical Data Management, Jubilant Clinsys
CHAIRPERSON
John Shillingford, PhD
Vice President, Strategic Initiatives, Aptiv Solutions, Germany
This session will look at the Early Phase Team’s decision-making processes,
use of adaptive designs to facilitate studies, and reduction of study times.
An integrated approach with the aim to facilitate rapid development go/
no-go decisions.
If Moses Could Cross the Red Sea, You Can Traverse the Valley
of Death
Gerald J. Yakatan, PhD
Chairman, CEO, and Founder, IriSys, Inc.
Into Patients, Timely but Safely, Using Integrated and Adaptive
Design Approaches
John Shillingford, PhD
Vice President, Strategic Initiatives, Aptiv Solutions, Germany
Use of Adaptive Designs in Dose Finding Studies
Joachim Vollmar, MSc
Chief Executive Officer, Prescos LLC
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Tuesday, June 26
Adaptive Optimal Model-based Designs in Drug Development
Abdul J. Sankoh
Senior Director, Vertex Pharmaceuticals
Managing the Drug Supply Demands of Adaptive Trial Designs
Graham J. Nicholls, MS
Director, Biostatistics, Almac Clinical Technologies LLC, UK
Practical Considerations in Designing and Monitoring Adaptive
Clinical Trials
Martin Kimber, PhD
Project Manager, Adaptive Clinical Trials, Tessella plc, UK
COMMUNICATIONS
Related Interest Area(s): MW, CR, RA
1:30 PM–3:00 PM
Room 108b
Practical Implementation of Bayesian Response Adaptive Designs:
Case Studies of Technology Approaches
Bill Byrom, PhD
Senior Director of Product Strategy, Perceptive Informatics, UK
LEVEL: ■
FORMAT: SYMPOSIUM
From Design to Disclosure: Pleasing Multiple
Masters
CHAIRPERSON
Tufts Center for the Study of Drug Development, Chairman, The Center for
Information and Study on Clinical Research Participation (CISCRP), Tufts
University
CLINICAL RESEARCH
Regulatory, scientific and operating requirements, concerns and objectives
are contributing to: (1) increased complexity in protocol designs, clinical
study report submissions, and study results reporting; (2) higher levels of
planning and operating inefficiency. This symposium explores opportunities
to realize substantial cycle time and cost savings through improvements in
protocol design planning, standardized clinical study report authoring and
the implementation of best disclosure practices.
Room 103b
1:30 PM–3:00 PM
Related Interest Area(s): VA, IT, QAQC
FORMAT: FORUM
Innovative Ways of Looking at Computer System
Validation
CHAIRPERSON
Vice President, Quality and Regulatory Affairs, Medidata Solutions
Worldwide
Minimizing Irrelevant and Unused Protocol Data and Reducing
Protocol Amendments
Tufts University
Much has been proselytized on computer systems validation (CSV) for
years. However, as the pharmaceutical industry has changed, and is still
changing, so the established dogma of CSV, with its associated mysticism
and time-consuming and costly practices is still proving stubbornly resistant
to modernization. This interactive panel session will discuss the key issues,
address the hurdles to change, and present a set of clear recommendations.
Clarifying ICH E3
Helle Gawrylewski, MA
Senior Director, Medical Affairs/Alliance Management, Regulatory
Medical Writing CoE, Janssen Pharmaceutical Companies of Johnson &
Johnson
Computerized Systems Validation: What if We Used Common Sense?
Uwe P. Trinks, PhD
Partner, Foresight Group, LLC
Panelists
Eric Staib
Director, Global IT Quality, Covance, Inc.
Mutually Exclusive Public Disclosure Regulatory Requirements
Uma Swaminathan, MBA, MSc
Senior Manager, Web Disclosure, Biologicals, GlaxoSmithKline, Belgium
Keith M. Parent, MS
Chief Executive Officer, Court Square Group Inc.
CLINICAL RESEARCH
1:30 PM–3:00 PM
LEVEL: ■
Pharmacy
#250 TRACK 08 – REGULATORY AFFAIRS AND SUBMISSIONS
Related Interest Area(s): CDM, EC, ST
LEVEL: ■
FORMAT: SESSION
1:30 PM–3:00 PM
Room 103a
Implementing Adaptive Clinical Trials: A Practical
Perspective
Related Interest Area(s): PR, CmbP, MDD
LEVEL: ■
FORMAT: SESSION
Room 120bc
An Ocean Apart? Integrating Distinct Health
Authority Philosophies on Personalized Medicines
and Companion Assays
CHAIRPERSON
Bill Byrom, PhD
Senior Director of Product Strategy, Perceptive Informatics, UK
CHAIRPERSON
Jeffrey N. Stuart, PhD, RAC
Senior Associate Director, Regulatory Affairs, Novartis Pharmaceuticals
Corporation
During the past decade we have seen increasing interest in adaptive trial
designs, and with the release of regulatory agency guidelines a cautious encouragement and acceptance of the methodology now prevails.
Nevertheless, while the promise of these designs is acknowledged, the
operational challenges in their implementation are less well understood.
Through three presentations, this session explores different aspects of
practical implementation of adaptive clinical trials in clinical development
programs. We will focus on practical implementation learning using case
study illustrations where possible.
Recently FDA and EMA released guidance to assist with co-development,
but creation of a global registration strategy remains challenging. This
session will bridge diverse regulatory perspectives to accelerate global
co-development efforts.
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Tuesday, June 26
Focus on Co-development: Issues to Consider when Contemplating
the Process
Elizabeth A. Mansfield, PhD
Director, Personalized Medicine, Office of In Vitro Diagnostics,
CDRH, FDA
Genomics Biomarkers Contribution to Personalized Medicines
Marisa Papaluca-Amati, MD
Head of Scientific Support and Projects, European Medicines Agency,
European Union
Room 115c
1:30 PM–3:00 PM
Related Interest Area(s): CR, CDM, QAQC
LEVEL: ■
FORMAT: SESSION
What Should You Put in a Clinical Quality
Assurance (CQA) Agreement
CHAIRPERSON
Charting the Regulatory Course for Global Co-Development of a
Therapeutic Product and Companion Diagnostic
Linda J. Burdette, PhD
Director, Hoffman-La Roche Inc.
Neil McCullough, PhD, MSc
Vice President, Global Quality and Compliance, PPD
This session will focus on how to properly develop, organize, and initiate a Clinical Quality Assurance (CQA). Discussions will include examples
of content categories, content, and experiences from speakers who have
developed and implemented a CQA.
1:30 PM–3:00 PM
LEVEL: ■
Sponsor QA Perspectives and Case Studies
JoAnna R. Brodie
Director, Clinical Quality Assurance Americas, GlaxoSmithKline
Related Interest Area(s): FI, RD
FORMAT: SESSION
Room 118c
Funding Innovation and Creating Opportunities in
the Device, Diagnostic, and Drug Interface
CRO QA Perspectives and Case Studies
Cassandra Kennedy
Senior Vice President, Global Quality Assurance, Quintiles
CHAIRPERSON
Daniel R. Matlis, MS
President, AXENDIA, Inc.
Current Industry Focus and Opportunities
Lisa McKay, MBA
Senior Director, Relationship Management Programs, The Avoca
Group Inc.
Funding is the lifeblood of innovation. In the current economic climate,
funding sources have become more difficult to obtain. This session will
cover the current environment for supporting innovation in the US, recent
trends, and identify strategies and sources for funding at the device, diagnostic, and drug interface.
Panelists
Donna Usiskin
Principal, Edison Ventures
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): CMC, RA, IT
FORMAT: SESSION
Room 119a
Practical Implementation of Knowledge
Management
Tom Olenzak
Managing Director, Drexel Partners, LLC
CHAIRPERSON
Georges L. France, PharmD, PhD
Head of Quality Assurance and Compliance, EU Region, Novartis Consumer
Health S.A., Switzerland
1:30 PM–3:00 PM
Room 113c
This session will discuss knowledge management (KM) during and after
QbD development. We will discuss key data to be considered, IT tools support, practical experience and debate about regulatory expectations.
Related Interest Area(s): RA, RD
LEVEL: ●
FORMAT: SESSION
Drug Rediscovery as an Innovative Tool to Meet
Unmet Medical Needs
FDA Point of View
Tara R. Gooen, MS
Team Leader, Office of Manufacturing and Product Quality, Office of
CHAIRPERSON
John A. Lisman, LLM, MPharm
Lawyer, Lisman Legal Life Sciences B.V., Netherlands
Drug Rediscovery is the science dealing with the use of old active substances to develop new treatments. This session focuses on the benefits
and challenges of drug rediscovery.
Carol A. Bye
Vice President, Head of Pharmaceutical Sciences Quality Assurance,
Pfizer Ltd., UK
Introduction to Drug Rediscovery
John A. Lisman, LLM, MPharm
Lawyer, Lisman Legal Life Sciences B.V., Netherlands
Inhaled Buformin for Lymphangioleiomyomatosis and Lung Cancer
Steven Lehrer, MD
President, Fermata Pharma Inc.
Drug Rediscovery in the Netherlands: 6-TG
Chris J. J. Mulder
Professor, Gastroenterology, VU University Medical Center, Netherlands
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Tuesday, June 26
1:30 PM–3:00 PM
PHARMACOVIGILANCE
1:30 PM–3:00 PM
LEVEL: ●
FORMAT: FORUM
Related Interest Area(s): CDM, CR, EC
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Registries for Evaluating Patient Outcomes:
Emerging Areas of Controversy
Room 118a
Stepping Up and Doing It Step by Step: Lessons
Learned from Initial Endeavors Exploring Health
Care Data for Signal Detection
CHAIRPERSON
CHAIRPERSON
Richard Gliklich, MD
President, Outcome
Preciosa M. Coloma, MD, MSc, RPh
Researcher, Erasmus University Medical Center, Netherlands
Presenters will introduce the third edition of "Registries for Evaluating
Patient Outcomes," a widely used guide describing best practices for
registries, and discuss emerging areas of controversy in registry design,
operations, and analysis.
Health care records are valuable data sources that can complement spontaneous reports. Experts from pioneering international initiatives will share
experiences and discuss challenges and lessons learned from preliminary
efforts using electronic health records (EHR) for signal detection.
Room 107ab
Introduction
Elise Berliner, PhD
Director, Technology Assessment Program, Agency for Healthcare
Research and Quality (AHRQ)
Does Spontaneous Report Data Mining Have a Future?
Alan M. Hochberg
Integrated Safety Risk Manager, F. Hoffmann-La Roche Ltd., Switzerland
Lessons from the Observational Medical Outcomes Partnership
Patrick Ryan, MS
Head, Epidemiology, Janssen Research & Development, LLC
Emerging Areas of Controversy in the Use of Patient Registries
President, Outcome
The EU-ADR Project and Perspectives on Inter-continental
Collaboration
Martijn Schuemie, PhD
Assistant Professor; Visiting Research Scientist, Observational Medical
Outcomes, Columbia University
PHARMACOVIGILANCE
1:30 PM–3:00 PM
LEVEL: ■
CME and Nursing
Related Interest Area(s): IS, RA
FORMAT: SESSION
Room 119b
Noninterventional Minimal Risk Research: A 360°
Perspective
THINKING
CHAIRPERSON
1:30 PM–3:00 PM
Linda M. Coleman, JD
Director of Regulatory Affairs and General Counsel, Quorum Review IRB
Room 113a
Noninferiority Trial Designs: Perspectives from
Academia, Industry, and a Regulatory Agency
In this interactive session, experts will explore the various types of noninterventional minimal risk studies (including postapproval noninterventional
studies, registries, safety-surveillance, and REMS) and their design to ensure
compliance with regulatory requirements. The session will also explore the
IRB, industry, and site perspective including the value of noninterventional
minimal risk studies and models for streamlining the IRB review process.
FORMAT: SESSION
LEVEL: ■
CHAIRPERSON
Weishi Yuan, PhD
Biomed Statistician, Office of Translational Sciences, CDER, FDA
There are more clinical trials done using noninferiority design in recent
years. In this session, we have invited experts from these three fields to discuss their perspectives on noninferiority designs, method, and experiences.
Kathleen A. Mandziuk, BSN, MPH, RN
Senior Scientific Affairs Director, PRA International
Not Noninferiority: Active Controlled Randomized Trial
Kevin J. Carroll, MSc
Statistician, AstraZeneca Pharmaceuticals LP, UK
IRB Perspective
Linda M. Coleman, JD
Director of Regulatory Affairs and General Counsel, Quorum Review IRB
Non-inferiority Trials in Oncology: A Regulatory Perspective
Rajeshwari Sridhara, PhD
Director, Division of Biometric V, Office of Biostatistics, Office of
Translational Sciences, CDER, FDA
Lindsay Crampton
Project Manager, PPD
Issues in Design and Analysis of Noninferiority Trials
Brent Logan, PhD
Professor, Division of Biostatistics, Medical College of Wisconsin
FDA Perspective
Acting Associate Director, Risk Science, Intelligence, and Prioritization,
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Tuesday, June 26
1:30 PM–3:00 PM
Related Interest Area(s): CR, IS, PETD
LEVEL: ■
FORMAT: WORKSHOP
1:30 PM–3:00 PM
Room 121c
Definition and Validation of Core Competencies
to Enhance the Quality of Clinical Trials and Those
Who Conduct Them
LEVEL: ●
Related Interest Area(s): CMC, CR, RA
FORMAT: FORUM
Room 117
SFDA Town Hall
CHAIRPERSON
Ning Li, MD, PhD
Vice President, GRA Head, Medical Policy, Asia, Sanofi, China
CHAIRPERSON
Director, Clinical Research Administration, Eastern Michigan University
Representatives from the State Food and Drug Administration, P.R.
China will provide updates on initiatives, guidances, and regulations in
their country, and the audience will have an opportunity to address the
esteemed panel.
Several groups have developed documents of core competencies required
of those involved in conduct of clinical research. This workshop will discuss
these efforts and provide participants an opportunity to validate competencies from the stakeholder perspective.
Clinical Trial Management in China
Jianan Wang
Pharmacist, State Food and Drug Administration (SFDA), China
Introduction to Newly Revised GMP Requirements
Huiping Chen
Senior Engineer, Center for Drug Certification, State Food and Drug
Administration (SFDA), China
Competencies for Principal Investigators and Pharmaceutical
Physicians
Honorio Silva, MD
President, Inter-American Foundation for Clinical Research (IAFCR)
Clinical Research Nurse Coordinator Competencies-Evolutions and
Collaborations
Carolynn J. Thomas-Jones, BSN, MPH, RN
Faculty Instructor, School of Nursing, University of Alabama at
Birmingham
1:30 PM–3:00 PM
Related Interest Area(s): PM, RD
FORMAT: SESSION
LEVEL: ■
Room 111ab
Understanding the Challenges of Conducting
Studies for Orphan Indications and Rare Diseases
CHAIRPERSON
Jackie Brown
Senior Project Manager, Premier Research Group Ltd.
1:30 PM–3:00 PM
LEVEL: ●
Related Interest Area(s): CMC, RA
FORMAT: SESSION
Conducting a research study for an orphan indication and/or rare disease
involves unique considerations in addition to the more common challenges
of clinical research. Key logistical and operational considerations will be
discussed including sharing of specific, relevant examples from different
therapeutic areas and clinical settings as well as strategies and techniques
to navigate the challenges. The session will also address specific examples
of materials, procedures and techniques developed and utilized for protocol/study design development, site identification and support, IRB/EC
approval, subject recruitment and retention, subject support, and program
timeline and budget management.
Room 122b
Update from the EMA-FDA Parallel Assessment
Pilot
CHAIRPERSON
This session will describe the scope of the EMA-FDA Parallel Assessment
Pilot for applications containing Quality-by-Design Information. The
purpose of this pilot, initiated in March 2011, is to help ensure consistent
implementation of ICH quality guidelines and to harmonize regulatory
decisions to the greatest extent possible. The progress on EMA-FDA parallel
assessment to date and perceived challenges will be addressed.
Protocol Development Considerations
H. Jeffrey Wilkins, MD
Chief Medical Officer, Ceptaris Therapeutics
Project Management Considerations
Jackie Brown
Senior Project Manager, Premier Research Group Ltd.
FDA Point of View
Subject Recruitment and Site Considerations
Tara O’Meara
Director, Clinical Operations, Synageva BioPharma Corporation
EMA Point of View
Emer Cooke, MBA
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Tuesday, June 26
1:30 PM–3:00 PM
LEVEL: ●
#265 TRACK 19A – SIAC SHOWCASE
Related Interest Area(s): CR, IT, RA
FORMAT: FORUM
3:30 PM–4:30 PM
Room 105ab
A Challenge for the Industry: What Will it Take
for a Sponsor to Use EHRs With a Regulated
Research Protocol?
Room 103a
Beyond Taxonomy
Related Interest Area(s): SE, CDM, EC
FORMAT: SIAC
LEVEL: ■
CHAIRPERSON
CHAIRPERSON
John M. Weiler, MD, MBA
President, CompleWare Corporation
Rebecca D. Kush, PhD
President and CEO, CDISC
This showcase will discuss the taxonomy of study endpoints and how this is
important in study design.
This forum will begin with a brief overview of current readiness for EHRs to
support regulated research and provide an opportunity for open discussion
with representatives of FDA and the HHS in terms of their views on the use
of EHRs for regulated research and the concerns that have discouraged
research sponsors from bringing this available opportunity into reality. A
challenge will be issued to sponsors to bring a protocol forward to use
EHRs for clinical research in an actual regulated research study. The forum
will also discuss value and opportunities for sponsors who lead the way for
the industry in leveraging EHRs to increase research capacity and efficiency.
Developed by the Study Endpoints (SE) SIAC.
John H. Powers, III, MD, FACP
Senior Medical Scientist, Collaborative Clinical Research Branch, NIAID,
SAIC/National Institutes of Health
CDER, FDA
Director, Office of Interoperability and Standards, Office of the National
Coordinator, Office of the Secretary, DHHS
#266 TRACK 19B – SIAC SHOWCASE
3:30 PM–4:30 PM
Jonathan S. Helfgott, MSC
Consumer Safety Officer, Division of Scientific Investigations, CDER, FDA
Room 103b
Related Interest Area(s): ST, CR, RA
LEVEL: ■
FORMAT: SIAC
CME and Nursing
Breaking News Update: Cutting Edge Statistical
Methods in Clinical Development
Jane Griffin, RPh
Director, Research Client Connect, Cerner Corporation
CHAIRPERSON
Jerald S. Schindler, DrPH
Vice President, Biostatistics and Research Decision Sciences, Merck Research
Laboratories
1:30 PM–3:00 PM
Related Interest Area(s): CR, RA, MW
LEVEL: ●
FORMAT: SESSION
The statistical methods used in drug development are changing rapidly. This
showcase will highlight the tip of the iceberg of the most important and
controversial methods just beginning to be deployed. We will also discuss
FDA reaction.
Room 125
The Unique Relationship Between Global Patient
Recruitment and Translation Management
Developed by the Statistics (ST) SIAC.
CHAIRPERSON
Matthew D. Rotelli, PhD, MS
Director – PK/PD, Bio-Medicines, Eli Lilly and Company
Diana L. Anderson, BSN, PhD, MSN
President, DAC Patient Recruitment Services
This White Paper Showcase explores solutions to key challenges clinical trial sponsors face in the recruitment arena including. 1) Ensuring
the Literal and Colloquial Accuracy of Translations; 2) Coordinating
Communication and Managing Data Files and 3) Managing the
Complexities and Time Involved in Translation of Materials for Patient
Recruitment.
FDA Perspective
Stephen E. Wilson, USPHS, DrPH
Director, Division of Biometrics III, CDER, FDA
#267 TRACK 19C – SIAC SHOWCASE
Brought to you by DAC Patient Recruitment Services.
3:30 PM–4:30 PM
staff member.
Room 121ab
CDER Electronic Submissions Standards Update
Panelist
Erica Kay Manning, JD
Project Manager, ClinicaLingua
3:00 PM–3:30 PM
Related Interest Area(s): SUBS, DM, CDM
LEVEL: ●
FORMAT: SIAC
CHAIRPERSON
Charles K. Cooper, MD
Medical Officer, Office of Translational Sciences, CDER, FDA
This showcase will explore CDER’s ongoing efforts to move towards electronic standards and how those standards will help the Center effectively
perform its critical public health mission. Topics include CDISC SDTM, ADaM
and the OSI site-level dataset.
REFRESHMENT BREAK
Exhibit Hall
Hosted by the Electronic Regulatory Submissions (ERS) SIAC.
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Tuesday, June 26
The showcase was developed by the Clinical Research (CR) SIAC, and presentations and attendee/speaker discussions will be used to develop future
CR SIAC initiatives and collaborations.
CDER Data Standards Program: Challenges and Progress
Mary Ann Slack
Deputy Director, Office of Planning and Informatics, CDER, FDA
Bioinformatics and Biotechnology: Issues of Complexity and
Collaboration
J. Michael Fitzmaurice, PhD, FACMI
Senior Science Advisor for Information Technology, Office of the
Director, Agency for Healthcare Research and Quality (AHRQ)
Site-Level Dataset Request for Clinical Investigator Site Selection
Paul Okwesili, Jr., MS
Operations Research Analyst, Office of Scientific Investigations, Office
of Compliance, CDER, FDA
Panelist
Joy Mele, MS
Statistical Reviewer, Office of Medical Products and Tobacco, Office of
Biostatistics, Office of Translational Science, CDER, FDA
Recent Questions about the Effective Use of Biomarkers
Richard M. Tresley, MD, PhD
Executive Director, Astellas Pharma US
#268 TRACK 19D – SIAC SHOWCASE
3:30 PM–4:30 PM
#270 TRACK 19F – SIAC SHOWCASE
Related Interest Area(s): EC, CDM, RA
LEVEL: ■
FORMAT: SIAC
3:30 PM–4:30 PM
Related Interest Area(s): CDM, EC, SE
FORMAT: SIAC
LEVEL: ■
Room 103c
Controversial Guidance, eSource and Standards:
How Does It All Fit Together in an eClinical World?
Room 105ab
Electronic Data Capture (EDC): How Much Quality
Is Enough?
CHAIRPERSON
CHAIRPERSON
Jonathan R. Andrus, MS
Vice President, Data and Study Operations, BioClinica, Inc.
Laurie S. Callen
Director, Clinical Data Management, Sunovion Pharmaceuticals
This showcase will aim to address the intricacies of navigating an ever
changing eClinical world. Presentations will be shared from a technology,
regulatory and standards perspective with an emphasis on how it all fits
together. With recently issued draft guidance, clinical research professionals are being encouraged to be more electronic in their approach to clinical
trials and to use more remote and central monitoring for clinical trials. The
end of the research silo era is near.
This is a complicated question that challenges many clinical study teams,
particularly with respect to Electronic Data Capture (EDC) systems. In an
effort to provide direction to these teams, a Clinical Data Management
(CDM) SIAC Working Group is exploring the changing expectations of data
quality as a result of EDC and the processes, procedures and tools recommended to optimize data quality.
Developed by the Clinical Data Management (CDM) SIAC.
Developed by the eClinical (EC) SIAC.
Ensuring Quality Control for Electronic Data Capture Systems
Scott Brand, PhD
Director of Strategic Planning and Quality Assurance, KAI Research Inc.
The Draft eSource Guidance — What Does It Mean to Me As a Site,
CRA and Data Manager
Joseph Dustin
Senior Business Consultant, Medidata Solutions Worldwide
Electronic Data Capture Quality: Define, Measure, and Deliver
Ellen Hinkle, MA
Clinical Data Specialist II, Vertex Pharmaceuticals
The Draft Risk Based Monitoring Guidance — What Does It Mean
For eClinical?
Joseph Schenk, MS
CEO, QA Edge, Inc.
#271 TRACK 19G – SIAC SHOWCASE
3:30 PM–4:30 PM
#269 TRACK 19E – SIAC SHOWCASE
3:30 PM–4:30 PM
LEVEL: ●
Related Interest Area(s): PETD, CR, RA
FORMAT: SIAC
Room 107ab
Emerging Professionals: Optimize your Transition
into the Pharmaceutical Arena
Related Interest Area(s): CR, BT, SP
LEVEL: ●
FORMAT: SIAC
Room 108a
Cross-sector Innovation Brings Tailored Therapies
to Patients
CHAIRPERSON
Yasmin de Faria Krim, PharmD
Manager, Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson
& Johnson, Belgium
CHAIRPERSON
Melvyn Greberman, MD, MPH, MS, FACPM
President, Public Health Resources, LLC
This showcase will highlight key points for optimizing the emerging professional’s transition into the pharma industry, including skill building, the
benefits of mentoring, and having a professional development plan.
This showcase will discuss targeted tailored therapy and its integral role in
the innovation of patient-centered care. The delivery of targeted tailored
therapies requires multidisciplinary collaborative product development and
continuous evaluation from bench to bedside. Innovation through translational research models, decision-making efforts during drug development,
and companion development of technology and devices are keys to the
future successful delivery of targeted tailored therapies and expansion of
diseases that may be treated.
Developed by the Emerging Professional Group (EP) SIAC.
Emerging Professionals: Pearls of Wisdom for Career Success
Sandra A. Wiejowski, PharmD, RPh
Senior Director, Global Medical Review, Abbott Laboratories
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Tuesday, June 26
#272 TRACK 19H – SIAC SHOWCASE
3:30 PM–4:30 PM
Developed by Clinical Pharmacology (CP) SIAC.
Related Interest Area(s): CEHTAEbM, PR, CR
LEVEL: ■
FORMAT: SIAC
Recent Development of Activities in Phase 1 Studies in Korea
Min Soo Park, MD, PhD
Professor, Vice President, Yonsei University; KoNECT, Republic of Korea
Room 108b
Evidence for the Marketplace: Bridging the Gap
Between Industry, Payer, Providers, and Patients
Early Drug Development in India- Opportunities and Challenges
Savita Dhillon, DrMed, MD
Medical Director, Medanta Duke Research Institute, India
CHAIRPERSON
Christopher M. Marrone, PharmD
Outcomes Liaison, Eli Lilly and Company
#275 TRACK 19K – SIAC SHOWCASE
This showcase will draw on senior experts from industry, payer, provider,
and patient stakeholder groups to offer unique perspectives on evidence.
Analyzing at times competing viewpoints of similar evidence, the panel
will offer insight into how similar evidence and outcomes can be viewed
differently by various market segments. Similarly, this panel will highlight
evidence needs that are specific to their needs in the hope of providing a
more complete picture of what constitutes a comprehensive definition of
"evidence of the market."
3:30 PM–4:30 PM
Room 113a
Good Pharmacovigilance Practice in a Global
Environment
CHAIRPERSON
Steve Jolley, MA
Principal, SJ Pharma Consulting
Developed by the Evidence Based Medicine (EBM) SIAC.
This showcase will present the challenges in conducting drug safety and
pharmacovigilance operations on a global basis and presents approaches
to the harmonization of good pharmacovigilance practice across regions to
accommodate many, if not most, regional requirements, while addressing
specific local requirements. Safety and risk management practices in the
EU, US, and Japan, including the new European pharmacovigilance legislation, are covered.
#273 TRACK 19I – SIAC SHOWCASE
3:30 PM–4:30 PM
LEVEL: ■
Related Interest Area(s): DM, RA, SUBS
FORMAT: SIAC
Room 109ab
Reference Models and the Framework for the
Destruction of Paper: How They Are Changing Our
Industry
Developed by the Clinical Safety and Pharmacovigilance (CSP) SIAC.
Good Pharmacovigilance Practice
Sally Van Doren, PharmD
President & Chief Executive Officer, BioSoteria, Inc.
CHAIRPERSON
Lisa D. Mulcahy
TMF Content Management Consultant, Mulcahy Consulting, LLC
What Are We Afraid of Against New EU Regulations?
Teiki Iwaoka, PhD, MS
Executive Consultant, Director of Drug Safety Outsourcing Planning,
CAC Corporation, Japan
The recent release of the Framework for the Destruction of Paper adds
to the already widely used reference models that have been developed
by the very active members of the Document and Records Management
(DRM) SIAC. Join this session to review the DRM SIAC’s mission and ongoing activities already underway including the released version 2.0 expansions of the Trial Master File Reference Model, the recent updates to the
EDM-Submission Reference Model and introduce the very newly finalized
Framework for the Destruction of Paper.
#276 TRACK 19L – SIAC SHOWCASE
3:30 PM–4:30 PM
Developed by the Document and Records Management (DRM) SIAC.
CHAIRPERSON
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC
EDM-Submission Reference Model: Introduction and Recent
Expansions
Antoinette M. Azevedo
General Manager, Sage Submissions
This showcase will discuss the ever changing clinical trial disclosure (CTD)
landscape, the impact on industry, and how companies change their processes to maximize efficiencies to meet the increasing demands of global
CTD requirements. Emerging CTD requirements in selected countries will
be highlighted. The showcase will also focus on results disclosure in the
EU as well as discuss the challenges and complexities companies face in
meeting global CTD requirements. An update will be provided on the status
of NLM's Notice of Proposed Rulemaking. In addition, the audience will be
encouraged to share their organizations' perspectives on these issues and
how they are meeting the challenges of clinical trial disclosure. Benefits of
participating in the SIAC will also be discussed.
#274 TRACK 19J – SIAC SHOWCASE
LEVEL: ■
PMI PDUs
Related Interest Area(s): MW, CR, QAQC
LEVEL: ■
FORMAT: SIAC
CME and Nursing
Room 113b
Hot Topics in Clinical Trial Disclosure (CTD)
TMF Reference Model: Introduction and Version 2.0 Expansions
Karen Jane Redding, MPharm
Director, Global Business Development, Phlexglobal Limited, UK
3:30 PM–4:30 PM
Related Interest Area(s): CP, RA, CR
LEVEL: ■
FORMAT: SIAC
Related Interest Area(s): CP, PC, CR
FORMAT: SIAC
Room 111ab
Globalization of Phase 1: Trends and Challenges
CHAIRPERSON
Developed by the Clinical Trial Disclosure (CTD) SIAC.
Director, Clinical Pharmacology, Duke University Medical Center
Significant Disclosure Developments in Selected Countries
John C. McKenney
President, SEC Associates, Inc.
This showcase will discuss trends, challenges and perspectives with speakers/
panelists who are directly involved in the globalization of early phase research.
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Tuesday, June 26
#279 TRACK 19O – SIAC SHOWCASE
The EU Clinical Trials Register: Practical Hurdles from a Company
Perspective
Merete Joergensen, MBA, MSc
Director, Global Clinical Registry, Novo Nordisk A/S, Denmark
3:30 PM–4:30 PM
Room 116
Leveraging Technology in an Age of Readily
Available Information
#277 TRACK 19M – SIAC SHOWCASE
3:30 PM–4:30 PM
Room 120bc
CHAIRPERSON
LEVEL: ■
FORMAT: SIAC
CME and Nursing
Natalie C. Gearhart, PharmD
Associate Director, Medical Information Center, Janssen Scientific Affairs, LLC
With the evolution of technology tools like smart phones and iPads, readily
available information is our current reality. This showcase will focus on new
ways to leverage technology to provide information and engage customers while building trust and credibility. Attendees will learn how to utilize
technology as an enabler in responding to requests.
Hot Topics in Regulatory Affairs Forum
CHAIRPERSON
Linda F. Bowen, MS, RAC
Head, Regulatory Policy and Intelligence-US, Sanofi
During this showcase, leaders from the labeling and regulatory intelligence
working groups will discuss hot and emerging topics in regulatory affairs.
Learn about current trends in industry, how companies are handling the
ever changing regulatory environment, and share approaches your organization may be leveraging.
Developed by the Medical Communications (MC) SIAC.
Advanced Use of Technology in Medical Affairs Communications
William R. Hahn, Jr.
President, Science Branding Communications
Developed by the Regulatory Affairs (RA) SIAC.
Medical Communications in the Pharmaceutical Industry: Stone Age
or Ahead of the Curve?
Natalie C. Gearhart, PharmD
Associate Director, Medical Information Center, Janssen Scientific
Affairs, LLC
Labeling Overview: Physicians Labeling Rule (PLR) and Beyond and
Updates in 2011–2012
Steven W. Bass, PhD
President, Bass Biopharm Consulting Group LLC
Regulatory Intelligence Topics
Brooke Casselberry, MS
Senior Manager, Regulatory Affairs and Writing Services, Liquent, Inc.
#280 TRACK 19P – SIAC SHOWCASE
3:30 PM–4:30 PM
LEVEL: ■
Related Interest Area(s): QAQC, GCP, RA
FORMAT: SIAC
LEVEL: ■
Room 115c
Meet the Regulators: Helping You Ensure GCP
Compliance by Knowing the Most Frequent and
Serious Findings
#278 TRACK 19N – SIAC SHOWCASE
3:30 PM–4:30 PM
Related Interest Area(s): MC, IT, AP
FORMAT: SIAC
LEVEL: ■
Related Interest Area(s): MW, MC, RA
FORMAT: SIAC
Room 113c
How Medical Writers Are Improving Global
Practice and Collaboration
CHAIRPERSON
Munish Mehra, PhD
Managing Director, Quantum Biopharma
CHAIRPERSON
This showcase will bring together regulatory authority compliance experts
from FDA and EMA who will share their perspective on inspections and
common areas of GCP noncompliance.
Jeannine Hanson, MS
Senior Manager, Global Regulatory Writing, Amgen Inc.
In this showcase, we will examine how medical writers in the SIACs are participating in regulatory and professional forums to improve the exchange of
information, and describe what those changes may look like. We will focus
on what we need to accomplish in the next 5 to 10 years to better meet
medical communication needs. Our objective is to inform members about
policy discussions and to encourage SIAC members to participate in these
forums.
Perspective from FDA/CDER
Leslie Ball, MD
EMA Perspective
Fergus Sweeney, PhD
Developed by the Medical Writing (MW) SIAC.
Developed by the Good Clinical Practice and Quality Assurance (GCP) SIAC.
Defining Medical Writing Profession: Contributions to Competency
and Certification
Contribution to Guidelines: DIA MW SIAC ICH E3 Task Force
Influences Q&A to ICH E3 Guidance
Nancy R. Katz, PhD
President and Principal Medical Writing Consultant, Illyria Consulting
Group, Inc.
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#281 TRACK 19Q – SIAC SHOWCASE
3:30 PM–4:30 PM
#283 TRACK 19S – SIAC SHOWCASE
Related Interest Area(s): OS, PM, QAQC
LEVEL: ■
FORMAT: SIAC
PMI PDUs
3:30 AM–4:30 AM
Related Interest Area(s): CDM, CP
FORMAT: SIAC
LEVEL: ■
Room 117
Navigating the Intersection of Outsourcing and
Quality Oversight
Pediatric Clinical Trials: Modeling and Simulation
to Support the Bridging of Data
CHAIRPERSON
CHAIRPERSON
Tiffany Sizemore Cherry, JD, MBA
CEO, Pharmcontrax, LLC
Gesine Bejeuhr, PharmD
Senior Manager, Regulatory Affairs/Quality, vfa Research-based
Pharmaceutical Companies, Germany
This showcase will explore regulatory expectations for managing service
providers via well-defined project governance and oversight processes.
Trends in the post-contract award process, including deliverable management and quality control where clinical trial sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors
will be discussed. Explore various structures of governance and oversight
and the outsourcing strategies they best support. In addition, panelists will
make recommendations on ways to ensure the process is effective, efficient,
and how to keep the operational teams focused on execution.
This showcase will provide practical
examples to illustrate the use of modelCANCELLED
ing and simulation in the planning and interpretation of pediatric clinical
trials, such as contraceptives in adolescents. How much do we know? Which
data can be extrapolated?
Developed by the Pediatric (PED) SIAC.
Director, GlaxoSmithKline
Developed by the Global Sourcing (GS) SIAC.
Designing an Optimal Third-Party Quality Oversight Program
John R. Wilson, PhD
Senior Vice President, Beaufort LLC
#284 TRACK 19T – SIAC SHOWCASE
Service Provider Governance and Oversight: Examples from the
Industry on the Balance Between Effectiveness and Efficiency
Todd Charles Reul
Clinical Outsourcing Consultant, Gilead Sciences, Inc.
Room 119a
3:30 PM–4:30 PM
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, CR, RA
FORMAT: SIAC
The Future of Project Management in the
Pharmaceutical Industry: What Competencies Will
Be Critical?
CHAIRPERSON
Martin D. Hynes, III, PhD
Senior Director, Six Sigma Champion, Research & Development, Eli Lilly and
Company
#282 TRACK 19R – SIAC SHOWCASE
3:30 PM–4:30 PM
Room 118a
Related Interest Area(s): CR, RA, CP
LEVEL: ■
FORMAT: SIAC
The biopharmaceutical industry has been employing novel drug development models in order to bring new drugs to the market in a timely and
cost-effective manner. This showcase will address the impact of these
changes on the discipline of pharmaceutical project management. The core
competencies for the pharmaceutical project manager of the future will be
described.
New Guidances on Quality Risk Management by
FDA and EMA: Implications for Industry
CHAIRPERSON
Kenneth J. Sprenger, MD, PhD
Executive Director, Medicine Team Leader, Pfizer Inc
Developed by the Project Management (PM) SIAC.
Recent publications by FDA on risk-based monitoring and EMA’s guidance
in risk-based quality management in clinical trials and the current discussions at Clinical Trial Transformation Initiative (CTTI) will have a major
influence on how clinical studies will be designed and conducted in the
future. Regulators have issued guidances that discuss and describe how an
approach to future quality management in clinical studies should look like.
The implications for clinical trials will be discussed by a Sponsor and a CRO
representative.
Managing Projects in the Pharmaceutical Industry: Why Is It
So Hard?
Innovative Drug Development Models: What Difference Can
They Make?
Charles T. Gombar, PhD
Senior Vice President, Project Management, Endo Pharmaceuticals
Holdings Inc.
Developed by the Quality Risk Management (QRM) SIAC.
Risk-based Approaches in Clinical Trials: A Regulatory Perspective
Acting Associate Director, Risk Science, Intelligence, and Prioritization
#285 TRACK 19U – SIAC SHOWCASE
3:30 PM–4:30 PM
Panelist
Vice President, Clinical Quality Assurance, Quintiles, UK
LEVEL: ●
Related Interest Area(s): PETD, RA, CR
FORMAT: SIAC
Room 119b
Re-energize Your Career!
CHAIRPERSON
Daniel F. Mudgett
Vice President, Knowledge Management, Medidata Solutions Worldwide
This showcase is directed at those professionals who seek more out of their
careers. Speakers will help provide the motivation and the techniques for
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Tuesday, June 26
self-improvement and personal satisfaction through career growth. The
panelist will help you take charge of your career right now! Proven steps to
move ahead and make your career more enjoyable and more rewarding will
be presented.
Real (and Practical) Electronic Healthcare Information System
Considerations
Earl W. Hulihan, MEd
Principal, ew hulihan and associates, inc.
Developed by the Professional Education, Training & Development
(PETD) SIAC.
#288 TRACK 19X – SIAC SHOWCASE
Position Yourself for Long-term Success With Three Proven, Yet
Underutilized Strategies
Ilyssa Levins
President, Center For Communication Compliance (CCC)
3:30 PM–4:30 PM
LEVEL: ■
Related Interest Area(s): IT, SP, ST
FORMAT: SIAC
Room 124
Who Owns the Service? Challenges in
Collaboration Between IT and the Business
#286 TRACK 19V – SIAC SHOWCASE
3:30 PM–4:30 PM
LEVEL: ■
CHAIRPERSON
Pamela Campbell, MBA
Senior Consultant, EMC Corporation
FORMAT: SIAC
Room 121c
Rx: A New World in Natural Health Products (NHP)
This showcase will examine how collaboration between IT and business
users can be improved through processes and tools while improving a company's competitive edge in an industry currently experiencing economic
and regulatory stress. Case studies will be presented.
CHAIRPERSON
Pradip K. Paul, MD, MS
Pharmacovigilance Consultant, Pharmacovigilance Consultant
Developed by the Information Technology (IT) SIAC.
Natural Health Products (NHP) is a rapidly growing area in the pharmaceutical and allied industry. Use of NHP as dietary, nutritional supplement or
herbal remedies is getting through revolutionary changes — particularly
with new initiatives of obtaining regulatory approvals. This showcase will
focus on the observed recent trends.
Implementing A Complex Statistical Analysis Environment With An
IT Savvy Business
Paulette V. Roper, MS
Director, Clinical Data Management THV, Edwards Lifesciences LLC
Maintaining Service Quality in a Shared Service Environment
Skip Garrison
Quality Assurance, Forest Laboratories, Inc.
Developed by the Natural Health Products (NHP) SIAC.
Why Big Pharmaceuticals Will Not Develop Polymolecular Natural
Health Products as Ethical (RX) Drugs
Freddie Ann Hoffman, MD
CEO, HeteroGeneity LLC
4:30 PM
Development of Botanical New Drug: Update on Regulatory Issues
Jinhui Dou, PhD
Botanical Review Team, Office of New Drugs, Office of Drug Evaluation
IV, CDER, FDA
OPEN BUSINESS MEETING
END OF TUESDAY
OFFERINGS
4:30 PM–6:30 PM
Room 120A
Adaptive Design Scientific Working Group
#287 TRACK 19W – SIAC SHOWCASE
3:30 PM–4:30 PM
Related Interest Area(s): CDM, CR, VA
LEVEL: ■
FORMAT: SIAC
CME and Nursing
The DIA Adaptive Design Scientific Working Group (ADSWG) is a multidisiplinary forum that enables noncompetitive collaboration on adaptive
designs. The group's vision is to ensure that adaptive designs are a wellunderstood, accepted, and broadly utilized approach (where and when
applied appropriately) in clinical research. In this session, an introduction
to the ADSWG, current activities and opportunities for getting involved
will be presented with opportunity for audience discussion. Also, recent
results from 2 of the topic focused sub-teams (Data Monitoring Committee
Processes and Approaches to Precision Medicine) will be presented.
Room 125
Status of the Use of Electronic Health Records
(EHR) in Clinical Research
CHAIRPERSON
Richard L. Chamberlain, PhD, MS
President, Executive Consultant Services
The showcase will discuss the current status of the use of Electronic Medical
Records (EMR) data in clinical research. Speakers will discuss their actual
experience with the use (or non-use) of these data.
Developed by the Validation (VA) SIAC.
Connecting Healthcare and Clinical Research
Mitra Rocca, MS
Senior Medical Informatician, Office of Translational Sciences, CDER, FDA
FDA CDER Perspective: Use of EHRs in Clinical Research
Jonathan S. Helfgott, MSc
Consumer Safety Officer, Division of Scientific Investigations, Office of
the Commissioner, CDER, FDA
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NOTES
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Wednesday, June 27
WEDNESDAY, JUNE 27
Related Interest Area(s): PM, CR, IT
FORMAT: FORUM
Registration Hours:
8:00 AM–9:30 AM
7:00 AM–5:00 PM
Broad Street Lobby
7:00 AM–5:00 PM
Room 109ab
Collaboration and Globalization of Clinical
Trials: What Does It Mean to Pharmaceutical
Project Managers?
Schedule:
LEVEL: ■
CHAIRPERSON
7:15 AM–8:00 AM
Matthew J. Kiernan, MBA
Partner, Pharmica Consulting
Tools to help study personnel have not kept pace with the needs of global
projects. With the advent of Web 2.0 technology, portals are a necessary
tool to manage trials. This forum will discuss how Web 2.0 fits into the clinical trial space.
8:00 AM–9:30 AM
9:00 AM–3:30 PM
9:30 AM–10:00 AM
Coffee Break
Exhibit Hall
10:00 AM–11:30 AM
11:00 AM–1:30 PM
Professional Poster Session #1 (see page 118)
Exhibit Hall D
11:30 AM–1:30 PM
Exhibit Hall
1:30 PM–3:00 PM
1:30 PM–3:30 PM
3:00 PM–3:30 PM
Refreshment Break
Exhibit Hall
3:30 PM–5:00 PM
5:15 PM–7:00 PM
Consortium of Academic Programs in
Clinical Research
Room 117
Collaboration and Globalization of Clinical Trials: What Does It Mean
to Pharmaceutical Project Managers?
Matthew J. Kiernan, MBA
Partner, Pharmica Consulting
R&D Collaboration: Enabling Drug Teams with SharePoint
Mark Yuzuk
Director of Collaboration Services, Bristol-Myers Squibb Company
SharePoint as a Collaborative Global Project Management Portal
Michael J. Connolley, MBA
Associate Director, Global Project Management, Daiichi Sankyo Inc.
STRATEGIC PLANNING
8:00 AM–9:30 AM
Room 108a
Related Interest Area(s): CR, PM, MC
FORMAT: SESSION
Room 105ab
Integrating Pharmacogenomics and Companion
Diagnostic Development into the Integrated
Clinical Development Plan
8:00 AM–9:30 AM
LEVEL: ■
Related Interest Area(s): CR, RA, CP
LEVEL: ■
FORMAT: SESSION
CHAIRPERSON
How Industry Can Partner with FDA in Defining a
Risk-based Monitoring Program
Michelle R. Smith, MS, PMP
Pharmaceutical Project Manager, Eli Lilly and Company
CHAIRPERSON
By integrating pharmacogenomics (PGx) and companion diagnostics (CDx)
into the clinical development plan in the early stages of drug development,
the clinical team can maximize their opportunity for tailored therapies and
minimize the risk of a CDx registration holding up drug approval.
Jan Holladay Pierre, MPH
Quality Principal Leader, Dynport Vaccine Company, LLC CSC
FDA encourages more effective monitoring of clinical trials through
their August 2011 draft guidance. Risk-based monitoring strategies and
approaches will be discussed from the FDA, sponsor and site perspectives,
and a focus on expected key changes in FDA's bioresearch monitoring
(BIMO) inspection program will be provided.
Integrating Pharmacogenomics into Clinical Development:
Unraveling the Mystery
Michelle R. Smith, MS, PMP
Pharmaceutical Project Manager, Eli Lilly and Company
Responding to FDA’s Guidance on Risk-based Monitoring
Terry Winchell
Consultant, GCP Innovative Dynamics, LLC
The Integration of IVD and Drug Development: Getting Started
Diane Rintzler Yen, PhD, PMP
Senior Project Manager, Merck Research Laboratories
What Risk-based Monitoring Means to a CRA
Robert Johnalan Milford
CRA, Beardsworth Consulting Group Inc.
K-Ras: A Case Study in Diagnostic Development
Christopher T. Harbison, PhD
Principal Scientist, Bristol-Myers Squibb Company
What Does a Risk-based Monitoring Program Look Like? A QA
Perspective
Jan Holladay Pierre, MPH
Quality Principal Leader, Dynport Vaccine Company, LLC CSC
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Wednesday, June 27
STRATEGIC PLANNING
8:00 AM–9:30 AM
LEVEL: ■
Risk-sharing Partnerships: Opportunity for Access and Quality
Edmund Pezalla, MD, MPH
National Medical Director for Pharmacy Policy and Strategy, Aetna
Related Interest Area(s): RA, SP, PM
FORMAT: SESSION
Room 103c
Asian Regulatory Agencies Relocated into Biotech
Science Park as a Strategy for Global Drug
Development
8:00 AM–9:30 AM
CHAIRPERSON
Asian regulatory agencies, like the Singapore Health Sciences Authority and
the Korea FDA, were relocated into biotech science parks, and Taiwan has
developed a strategy of a supra-incubator center to become a proactive
supporter of global drug development. In this session, we will examine
these strategies and outcomes of new drug development from Singapore,
Korea, and Taiwan.
CHAIRPERSON
Craig Martin
Chief Executive Officer, Feinstein Kean Healthcare
This session provides insights into the rapidly emerging world of collaborations between pharma and patient advocacy organizations to accelerate
basic and clinical research by leveraging the data and participation from
patients.
Regulatory Consultation of Taiwan Supra Integrated and Incubation
Center (SIIC) for Drug Development
Herng-Der Chern, MD, PhD
Distinguished Research Fellow, Center for Drug Evaluation, Taiwan
Advocacy 3.0: A New Model Through Technological Innovation
William Anthony Tulskie, MS
CEO, Healthcare IT, Inc.
Regulatory Authorities and Company Co-location in Science Parks:
Romi Singh, PhD
Executive Director, Global Regulatory Affairs and Safety, Amgen Inc.
Accelerating Personalized Medicine in Myeloma: Foundation
Perspective
Louise Perkins, PhD, MS
Chief Scientific Officer, Multiple Myeloma Research Foundation
PMDA Perspective
Tsuyoshi Ando, PhD
Deputy Manager, Office of Review Management, Pharmaceutical Affairs
Consultation Group on R&D Strategy, Pharmaceuticals and Medical
Devices Agency (PMDA), Japan
Accelerating Personalized Medicine in Myeloma: Pharmaceutical
Perspective
George J. Mulligan, PhD
Senior Scientist, Milennium Pharmaceuticals
LEVEL: ■
Related Interest Area(s): OS, CR, SP
FORMAT: SESSION
Room 111ab
Patient Advocacy and Your Next Generation of
Research: How Nonprofit Organizations Can
Accelerate Product Development
8:00 AM–9:30 AM
LEVEL: ●
Related Interest Area(s): OS, SP, FI
FORMAT: FORUM
8:00 AM–9:30 AM
Room 108b
PMI PDUs
Risk-sharing Partnerships: Models for Managing
Risk across the Clinical-Commercial Continuum
Related Interest Area(s): BT, PC, NC
LEVEL: ●
FORMAT: SESSION
CME and Nursing
Room 124
Nanotechnology: Regulatory Challenges and
Opportunities
CHAIRPERSON
Patrick Jordan, MBA
Vice President, Global Customer Solutions, Quintiles
CHAIRPERSON
Joseph C. Scheeren, PharmD
Senior Vice President, Head Global Regulatory Affairs, Bayer Healthcare
Pharmaceuticals
In the current health care landscape, never has there been so much risk or
opportunity to develop and commercialize new therapeutics. In this forum,
we will share different perspectives on nontraditional pharma partnerships
that are designed to reduce risk and enhance innovation, including a CRO
perspective to talk about ways to manage operational risk, a third-party
capital perspective on managing financing risk, and a payer perspective
on how pharma can manage commercial risk by partnering earlier on
reimbursement strategy.
This session will provide an overview on FDA's approach on regulating
products with nanotechnology. There will also be a focus on industry case
studies on experiences and challenges with nanotechnology development.
FDA’s Approach on Regulating Products with Nanotechnology
Ritu Nalubola, PhD
Senior Policy Advisor, Office of Policy, Office of the Commissioner, FDA
Case Study: Innovative Partnering Models for More Profitable Drug
Development
Tim Dietlin, MBA
Vice President, Alliance Development, INC Research, Inc.
Frontiers in Nanomedical Development: An Academic Perspective
Kathleen K. Eggleson, PhD
Research Scientist, Center for Nano Science and Technology, University
of Notre Dame
Product-Based Investing in BioPharma
William Robb, MBA
Partner, NovaQuest Capital Management
Co-Founder, President and Chief Executive Officer, CytImmune
Sciences, Inc.
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Wednesday, June 27
#308 TRACK 05 – PRODUCT ADVERTISING AND MARKETING
8:00 AM–9:30 AM
LEVEL: ●
CLINICAL RESEARCH
Related Interest Area(s): RA, CP, MC
FORMAT: WORKSHOP
Room 113b
Pharmacy
8:00 AM–9:30 AM
Room 103a
Combining Patient Self-report and Clinician
Oversight: Are Two Heads Better than One?
CHAIRPERSON
Janet L. "Lucy" Rose
President, Lucy Rose and Associates, LLC
CHAIRPERSON
John Greist, MD
CEO, Distinguished Senior Scientist, Madison Institute of Medicine,
Healthcare Technology Systems
This interactive workshop will provide a basic introduction to the regulation
of prescription drug advertising and promotion. The speakers will cover
such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.
This session will address the roles of patients in providing, and clinicians in
acquiring and evaluating, subjective patient experiences and the process
of converting patient experience into analyzable data. Factors addressed
will include accessibility to subjective experience, competence to judge
symptomatology, subject sensitivity, method of assessment, and variability
between patient reports and professional assessments. Using suicidality as
an example, approaches to balancing different but overlapping perspectives
and integrating them into an accurate whole will be discussed.
more participants will be admitted. Interested attendees are encouraged to arrive at workshops early
in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
FDA Point of View
Michael A. Sauers
Lead Consumer Safety Officer, Office of Prescription Drug Promotion,
Office of Medical Policy, CDER, FDA
Challenges in Developing Composite Clinical Endpoints: Clinician
and Patient Reported Outcomes in Aesthetic Indications
Jean Paty, PhD
Founder and Senior Vice President, Scientific, Quality and Regulatory
Affairs, invivodata, Inc.
COMMUNICATIONS
8:00 AM–9:30 AM
Room 121c
Related Interest Area(s): CDM, EC, SE
FORMAT: SESSION
LEVEL: ■
Suicidality Monitoring: The Time for Technology Has Come
John Greist, MD
CEO, Distinguished Senior Scientist, Madison Institute of Medicine,
Healthcare Technology Systems
Related Interest Area(s): MW, CMC, DM
LEVEL: ●
FORMAT: WORKSHOP
Implementing Structured Authoring: Understanding
the DITA Model and Its Applicability for Content
and Metadata Management
A Sponsor’s Experience Managing Data From Patient and Clinician
Perspectives on Suicidality
Carl Gommoll, MS
Director, Clinical Development, Forest Research Institute
CHAIRPERSON
Michael J. Brennan, PhD
Director, Informatics, Johnson & Johnson Pharmaceutical Research &
Development, LLC
CLINICAL RESEARCH
This workshop will describe the applicability of the DITA (Darwin
Information Typing Architecture) Model for the creation and management
of pharmaceutical documentation. This workshop will describe the experience of different pharmaceutical companies to implement content design.
8:00 AM–9:30 AM
LEVEL: ■
Related Interest Area(s): EC, CDM, IT
FORMAT: SESSION
Room 103b
eClinical Interoperability: Imagination, Integration,
Implementation
more participants will be admitted. Interested attendees are encouraged to arrive at workshops early
in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
CHAIRPERSON
Anne M. Zielinski, MBA
Vice President, Alliances, Medidata Solutions Worldwide
The Paradigm Shift to Structure Content Management: Bringing
Change and Agility
Michael Robbins, MS
Domain Manager, TIM Solutions Delivery and Integration, CSM, Sanofi
Moving from the vision of end-to-end interoperability to reality requires
informed decisions, reformed processes, and realistic planning and expectations. This session examines clinical systems’ interoperability, starting with
the end in mind.
Using Information Standards to Drive eClinical Interoperability
Samuel W. Hume, MS
Director, IS Architecture, AstraZeneca Pharmaceuticals LP
A Measured Approach to Clinical Systems Integration
Kenneth Grice
Associate Director, ePRO Operations, Bayer Healthcare Pharmaceuticals
Interoperable Systems: Implications for Process Design and Change
Management
Christie Mahoney
Partner, Soltex Consulting
83
Wednesday, June 27
8:00 AM–9:30 AM
Related Interest Area(s): RA, CR, CP
LEVEL: ●
FORMAT: SESSION
CME and Nursing
8:00 AM–9:30 AM
Related Interest Area(s): RA, CR, MW
FORMAT: SESSION
CME and Nursing
LEVEL: ■
Room 119a
Patient Advocacy in Medical Product Development:
The Evolving Relationship Between FDA and Its
Patient Stakeholders
Room 119b
Clinical Trial Disclosures: A US and EU Regulatory
Update
CHAIRPERSON
Barbara Godlew, RN
President, The FAIRE Company, LLC
CHAIRPERSON
James E. Valentine, MHS
Program Analyst, Office of Special Health Issues, Office of the
Commissioner, FDA
This session focuses on US and EU requirements for clinical trial disclosures.
Information obtained during this session will include results reporting
as it applies to regulatory, clinical operations, medical writing, and other
related areas.
This session will explore the role of patient advocates in FDA decisionmaking. FDA will describe its patient advocacy programs and the value
they have added. A patient representative will discuss their interactions and
experience with the agency.
Operational Challenges of Coordinating Submissions to
ClinicalTrials.gov and European Medicine’s Agency Clinical Trial
Registry
Tracy J. Beck, PhD
Consultant-Clinical Trial Registry Office, Eli Lilly and Company
Patrick Frey
Director, Office of Planning and Analysis, CDER, FDA
Marcia K. Horn
President and CEO, International Cancer Advocacy Network
EMA Point of View
Senior Medical Officer, European Medicines Agency, EU
Marc M. Boutin, JD
Executive Vice President and Chief Operating Officer, National Health
Council
NIH Point of View
Rebecca J. Williams, PharmD, MPH
Assistant Director, ClinicalTrials.gov, National Library of Medicine, NIH
8:00 AM–9:30 AM
LEVEL: ●
FORMAT: SESSION
Room 120bc
Future Directions for eCTD Module 1
8:00 AM–9:30 AM
Related Interest Area(s): CP
LEVEL: ●
FORMAT: SESSION
Room 118c
Oncology Medications: State-of-the-art
Identification and Management of Potential CV
Safety Issues During Development
CHAIRPERSON
Gary M. Gensinger, MBA
Deputy Director, Office of Business Informatics, Center for Drug Evaluation
and Research, FDA
CHAIRPERSON
Discussion will include key changes to Module 1, including incorporating the eCTD standard into the review of promotional materials. Also
included will be reviewer concerns, file types accepted and presentation of
specific examples.
Philip T. Sager, MD, FACC
President, Sager Consulting Experts
Increasingly cardiac safety issues have arisen as a concern in the development of oncology medications. This session will focus on the potential
safety issues of cardiotoxicity and QT prolongation and arrhythmogenesis
and discuss their identification and potential management strategies. In
addition, a state-of-the-art framework for collecting potential cardiac safety
adverse events will be discussed and audience participation will be encouraged. The attendee will gain deeper theoretical and practical insight into
the cardiac safety evaluation and risk-management of oncology medications during their development.
eCTD Module 1 Update
Constance Robinson, RAC
Regulatory Information Specialist, Office of Business Informatics, Office
of Planning and Informatics, CDER, FDA
Panelists
Marci C. Kiester, PharmD
Associate Director, Office of Prescription Drug Promotion, CDER, FDA
This session is hosted by Cardiac Safety Research Consortium (CSRC).
Mark A. Gray
Director, Division of Data Management Services & Solutions, CDER, FDA
QT, Electrocardiographic and Arrhythmia Assessment for Oncologic
Agents
Philip T. Sager, MD, FACC
President, Sager Consulting Experts
Overview of Myocardial Cardiotoxicity Assessment During
Development
Daniel J. Lenihan
Director of Clinical Research; Honorary Member of the International
CardiOncolog, Vanderbilt University
84
Wednesday, June 27
Proactive Assessment of Potential Cardiac AE's Using Standardized
Methodology
John K. Finkle, MD
Director, Cardiovascular Therapeutic Area, GCSP, GlaxoSmithKline
8:00 AM–9:30 AM
Room 122b
Auditing Pharmaceutical Quality Systems
Panelist
CHAIRPERSON
Joseph C. Famulare
Global Head of Compliance and External Collaboration, Genentech, A
Member of the Roche Group
8:00 AM–9:30 AM
LEVEL: ■
Pharmacy
A robust pharmaceutical quality system includes a well thought-out
auditing program for self audits of contract manufacturing organizations,
suppliers and their distribution chain. This provides senior management key
information to ensure quality.
FORMAT: FORUM
Room 113c
Policy and Enforcement Trends: Are Regulators
and Industry Heading in the Right Direction?
Internal Audits: US Policy and Benefits Under a US Quality System
Branch Chief, International Compliance Branch, Division of
Manufacturing and Product Quality, Office of Compliance, CDER, FDA
CHAIRPERSON
Barry A. Berger, JD, MBA
Professor of Regulatory Affairs, Temple University
Leveraging Independent Audits to Enhance Your Quality System:
An Industry Perspective
Elain Eborall
Director, Audit Americas, Genentech, A Member of the Roche Group
This forum will explore policy and enforcement trends and explore issues
addressing questions related to the issue of whether regulators/industry are
heading in the right direction. As globalization and collaboration become
more relevant, can we do better?
European View of Benefits and Requirements to Perform Internal
GMP Audits
Ian Jackson
Operations Manager, Medicines and Healthcare products Regulatory
Agency (MHRA), UK
FDA Perspective on Policy and Enforcement Trends
Eric M. Blumberg, JD
Deputy Chief Counsel for Litigation, Office of the Chief Counsel, Office
of the Commissioner, FDA
William Kitchens, JD
Partner, Arnall Golden Gregory LLP
William W. Vodra, JD
Retired Partner, Arnold & Porter LLP
8:00 AM–9:30 AM
Related Interest Area(s): PR
FORMAT: SESSION
LEVEL: ■
Room 107ab
Environment for Health Care Decision Making:
The Role of CER, Evidence-based Medicine,
Quality, and Value
8:00 AM–9:30 AM
Related Interest Area(s): CMC, MF
FORMAT: SESSION
CME and Nursing
LEVEL: ■
CHAIRPERSON
Kimberly Westrich, MA
Research Director for Health Services Research, National Pharmaceutical Council
Related Interest Area(s): GCP, RA, QAQC
LEVEL: ■
FORMAT: SESSION
Room 121ab
FDA and European Medicines Agency
Collaboration: GCP Inspections and Beyond
This session will provide an overview of the role of comparative effectiveness research (CER) in the current environment for health care decision
making. Specific components will include the results of two rounds of
surveys of health care influentials on the state of the environment for health
care decisions, good practice principles for CER, and case studies focusing
on the synergy between CER and quality measures.
CHAIRPERSON
Leslie Ball, MD
Stakeholder Survey: The State of CER and the Environment for
Decision Making
Kimberly Westrich, MA
Research Director for Health Services Research, National
Pharmaceutical Council
This session will discuss the progress of the FDA and EMA GCP initiative,
present areas of current focus, and preview future collaborations on inspections as well as GCP policy and guidance.
EMA Perspective
Fergus Sweeney, PhD
Good Practice Principles for CER
J. Sanford Schwartz, MD
Professor of Medicine, Health Care Management, and Economics,
University of Pennsylvania
FDA Perspective
Karena Cooper, JD
Regulatory Counsel, Office of Compliance, CDER, FDA
Comparative Effectiveness Research (CER): A Tool for Driving
Payment and Delivery Reform Case Studies
Nader Halim, PhD, MBA, MPH
Senior Consultant, Quintiles
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Wednesday, June 27
PHARMACOVIGILANCE
8:00 AM–9:30 AM
LEVEL: ■
Core Methodologies in Safety Surveillance Systems: Quantifying
Success and Identifying New Directions
Jeremy Rassen, DrSc
Assistant Professor of Medicine; Division of Pharmacoepidemiology &
Pharmacoeconomics, Brigham & Women’s Hospital, Harvard Medical
School
Related Interest Area(s): CmbP, RA, CR
FORMAT: SESSION
Room 115c
How to Be Prepared for Shifting Regulations on
THINKING
CHAIRPERSON
Regulations for combination products have remained in flux in recent times,
which has affected the approach and execution of safety processes. This
session will examine what re-tooling is required by companies in light of
new regulations.
8:00 AM–9:30 AM
Room 113a
Statistical Methods for Analysis of Integrated
Safety Data
Overview of the Continuing Global Regulatory Landscape Changes
Relating to Post Market Surveillance of Combination Products and
Practical Challenges and Implications: An Industry Perspective
CHAIRPERSON
Xiaoming Li, PhD
Director, Biostatistics, Gilead Sciences, Inc.
In clinical development, safety profile of the candidate pharmaceutical/biological product became more and more important, given that there is more
likely an existing treatment for the target disease on the market and the
potential target population growth. Accordingly, development of statistical
methods that can be applied for safety analyses have drawn much attention
lately. In this session, industry and regulatory agency speakers will discuss
the new developments in this important area.
An Overview and Implications From an Industry Networking Group,
Including Guiding Principles
Ajay Keshava, MS
Managing Consultant, WCI Consulting Limited
Regulatory Reporting on Combination Products: Device
Manufacturer’s Perspective
Patrick Caines, PhD, MBA
Director, Postmarket Surveillance, Boston Scientific Corporation
Multivariate Bayesian Logistic Regression for Analysis of Clinical
Trial Safety Issues
William DuMouchel, PhD
Chief Statistician, Oracle Health Sciences
PHARMACOVIGILANCE
8:00 AM–9:30 AM
Room 118a
Related Interest Area(s): CEHTAEbM, CR, CDM
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Integrated Summaries of Safety: Evaluating a Difference in
Proportions across Potentially Heterogeneous Studies
David Radley
Associate Director, Biostatistics and Research Decision Science, Merck
& Co., Inc.
Related Interest Area(s): EC, CDM, ST
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Active Surveillance Using Large, Electronic Health
Care Data Networks
FDA Perspective
Ram Tiwari, PhD
Associate Director for Statistics, Office of Biostatistics, Office of
CHAIRPERSON
Robert Reynolds, DrSc, MSc, FISPE
Vice President, Global Head, Epidemiology, Pfizer Inc
This session will provide a summary of the key operational and methodological issues facing the implementation of active surveillance in electronic
health care data, drawing on lessons learned from the FDA's Sentinel
Initiative and pilot project, Mini-Sentinel and the Observational Medical
Outcomes Project (OMOP). Speakers will identify which approaches have
been successful and the challenges that lie ahead.
8:00 AM–9:30 AM
LEVEL: ■
Related Interest Area(s): CR, PM, PETD
FORMAT: SESSION
Room 117
Emerging Needs in Clinical Research and Drug
Development Sciences Education and Certification
This session is hosted by the International Society for
Pharmacoepidemiology (ISPE).
CHAIRPERSON
Distributed Electronic Health Data Networks for Medical Product
Safety Surveillance
Jeffrey Brown, PhD
Assistant Professor, Department of Population Medicine, Harvard
Pilgrim Health Care Institute/Harvard Medical School
Honorio Silva, MD
President, Inter-American Foundation for Clinical Research (IAFCR)
The preliminary results of an international initiative aimed to assess the
training and education needs, and the perceived value of certification to
ensure quality will be contrasted with the profile of core professional competencies for clinical researchers. The status of clinical research and pharmaceutical medicine in Asia and the potential value of regional programs
will also be discussed.
Opportunities for Leveraging National Surveillance Research Efforts
to Improve Industry Pharmacovigilance Operations
Patrick Ryan, MS
Head, Epidemiology, Janssen Research & Development, LLC
Aligning Competencies and Education Needs
Director, Clinical Research Administration, Eastern Michigan University
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Wednesday, June 27
Pharmaceutical Medicine and Clinical Research Education in Asia
Jean-Paul M.F. Deslypere, MD, PhD
CEO, Proclin Therapeutic Research, Singapore
9:30 AM–10:00 AM
Exhibit Hall
Certification Systems for Trial Professionals: Effective Measure for
Quality Assurance?
Min Soo Park, MD, PhD
Professor, Vice President, Yonsei University; KoNECT, Republic of Korea
10:00 AM–11:30 AM
LEVEL: ■
Related Interest Area(s): CR, PM, SP
LEVEL: ■
FORMAT: SYMPOSIUM
CME and Nursing
Room 109ab
Clinical Research in Emerging Regions Around the
World
8:00 AM–9:30 AM
COFFEE BREAK
Related Interest Area(s): RA, MF, CP
FORMAT: FORUM
CHAIRPERSON
Room 115a
Ashok K. Ghone, PhD
Vice President, Global Services, MakroCare
CHAIRPERSON
Regions such as Asia Pacific Emerging Countries, Central and Eastern
Europe, and Latin America are the dynamic emerging markets and preferred destinations for clinical trials. This symposium will cover current
conditions and will demonstrate key factors of success in planning and
managing clinical trials in the regions, based on lessons learned.
Connie T. Jung, PhD, RPh
Acting Associate Director, Policy and Communications, Office of Drug
Security, Integrity & Recalls, Office of Compliance, CDER, FDA
This town hall is intended to be an open forum discussion on the risks to
human drugs created by complex global supply chains, greater foreign
sourcing of products and the increase in volume of imports along with current efforts by regulators and industry to ensure product safety and quality.
Clinical Trials in Emerging Regions: Focus on Asia Pacific Region
Ashok K. Ghone, PhD
Vice President, Global Services, MakroCare
Threats and Vulnerabilities to Supply Chain Security
S. Leigh Verbois, PhD
Acting Deputy Director, Division of Supply Chain Integrity, Office of
Drug Security, Integrity & Recalls, FDA
Programming Success in Clinical Trials: Focus on Russia, Ukraine and
other ex-USSR Countries (from Feasibility to Close Out)
Andrei Kravchenko, MD, PhD
Head of Representative Office in Ukraine, Harrison Clinical Research
Deutschland GmbH, Ukraine
Targeting Counterfeit Drugs
Gregg Goneconto
Special Agent, Office of Criminal Investigations, FDA
Which Were the Challenges in a Real Case Epidemiological
Population-based Trial in Brazil Comparing with a Clinical Trial?
Daniel Prado
Clinical Research Manager, RPS (ReSearch Pharmaceutical
Services, Inc.), Brazil
Compliance and Inspection Sector
Deputy Head, Austrian Medicinal and Medical Device Agency (AGES),
Austria
8:00 AM–9:30 AM
LEVEL: ●
FORMAT: SESSION
10:00 AM–11:30 AM
Room 125
Enabling Remote Monitoring in Clinical Trials for
Sponsors and Sites
LEVEL: ■
Related Interest Area(s): PM, IT
FORMAT: SYMPOSIUM
Room 108a
CME and Nursing
Applying Longstanding Ethical Principles in a
Period of Dynamic Change
CHAIRPERSON
CHAIRPERSON
William Baker, MBA
President/CEO, Cape Cod Clinical Research, Inc. (CCCRI)
Bonnie A. Brescia
Founding Principal, BBK Worldwide
This White Paper Showcase will interpret the FDA's 2011 "Draft Guidance
for Industry Oversight of Clinical Investigation-A Risk-based Approach"
and highlight the implications for organizations conducting clinical
research. It will also explore alternative methods to monitoring and
detail how sponsors and investigative sites can incorporate remote
monitoring into their future trial design and monitoring plans.
Review boards and regulatory committees are increasingly challenged by
new technologies that impact patient protections and ethical considerations
in clinical study planning. This symposium will explore how IRBs and ethics
committees can apply basic principles of research ethics in the context of
evolving value considerations in clinical research. The speakers will address
issues such as: new definitions of autonomous action in a digitally enabled
information age; applying the height of efficacy bar in the review process;
the ongoing struggle to obtain true informed consent; and the cultural and
generational differences in the definition of privacy.
Brought to you by Cape Cod Clinical Research, Inc.
Attendee badges scanned for this White Paper Showcase will be shared with the Company hosting
this offering. If you prefer not to have your badge scanned, please inform the DIA staff member.
Protecting Study Participants: The Ethics of Privacy, Transparency,
and Trust in a Digital Age
Bonnie A. Brescia
Founding Principal, BBK Worldwide
Donna W. Dorozinsky, MSN, RN
President, DWD & Associates, Inc.
Patrick D. Stone, MS
Founder, TradeStone QA LLC
IRB Reviews. How High Must the "Efficacy Bar" Be?
Jon Holmlund, DrMed
Medical Director, Aspire IRB
Joshua Sharlin, PhD
President, Sharlin Consulting
87
Wednesday, June 27
STRATEGIC PLANNING
10:00 AM–11:30 AM
LEVEL: ●
This forum will provide an overview of the Bill & Melinda Gates Foundation’s
work and describe its "Decade of Vaccines" effort. Panelists will also
address a partnership for tuberculosis drug discovery, examples of product
development partnerships, and a project on postmarket drug and vaccine
surveillance in low- and middle-income countries.
Related Interest Area(s): MC, PETD, PM
FORMAT: FORUM
Room 105ab
Achieving Alignment in a Difficult and Diverse
Environment
A Partnership for Tuberculosis Drug Discovery
Ken Duncan, PhD
Deputy Director, Global Health Discovery, Bill & Melinda Gates
Foundation
CHAIRPERSON
Atsushi Tsukamoto, MSc, PMP
Global Project Manager, Global Project Management Department, Daiichi
Sankyo Co., Ltd., Japan
Introduction to the Gates Foundation's Global Health Strategy and
Regulatory Priorities
Vincent I. Ahonkhai, MD
Senior Regulatory Officer, Global Health Delivery, Bill & Melinda Gates
Foundation
Smooth communication is a critical success factor in the recently diverse
global environment. Panelists will offer concrete frameworks to apply in
determining the best methods of communication in various situations, e.g.,
managing difficult people and senior management.
Opportunities for Transformation: Strategies for Patient Safety
Surveillance in Low- and Middle-income Countries
Amrit Ray, MD, MBA
Chief Safety Officer; Head Global Medical Safety, Janssen Research &
Development, LLC
Establishing and Policing Ground Rules and Protocols for Successful
Meetings in Diverse Teams
Robert A. Hilke, MA
CEO, Hilke Communications, LLC, Japan
Article 58 — Pyramax
David Reddy, PhD
Chief Executive Officer, Medicines For Malaria Venture (MMV),
Switzerland
Different Styles of Decision-making in Global Teams
Gareth Julian Monteath, MBA, MS
Program Director, INTEC Japan Inc., Japan
Global Pharmaceutical Project Team Case
Atsushi Tsukamoto, MSc, PMP
Global Project Manager, Global Project Management Department,
Daiichi Sankyo Co., Ltd., Japan
10:00 AM–11:30 AM
STRATEGIC PLANNING
10:00 AM–11:30 AM
LEVEL: ■
Room 124
Can Human Carcinogenic Risk Be Communicated
Without a Rodent Bioassay?
FORMAT: WORKSHOP
CHAIRPERSON
Room 121c
PMI PDUs
Project Risk Management Simulation for Product
Development
Joy A. Cavagnaro, PhD, RAC
President, Access BIO
Has our understanding of carcinogenicity advanced sufficiently that data
from alternative assays could be used to support decisions that are as
protective of the public health as are current approaches?
CHAIRPERSON
Karla Childers
Project Manager, Merck Research Laboratories
The Two-year Bioassay as a Carcinogenesis Screen: A Useless and
Often Misleading Waste of Resources
Samuel M. Cohen, MD, PhD
Professor of Pathology and Microbiology, University of Nebraska
Medical Center
This workshop will give participants hands-on experience in facilitating
an interactive project risk management exercise, including practice in risk
identification and prioritization and group facilitation.
Carcinogenicity Risk of Biotechnology-derived Pharmaceuticals:
Assessment of Carcinogenic Risk Without a 2-Year Bioassay
Ronald W. Steigerwalt, PhD
Preclinical Director, Toxicology, Amgen Inc.
10:00 AM–11:30 AM
LEVEL: ●
Related Interest Area(s): BT, PC
FORMAT: FORUM
LEVEL: ◆
A Proposed Vision on the Future of Carcinogenicity Testing
David Jacobson-Kram, PhD
Associate Director for Pharmacology and Toxicology, Office of New
Drugs, CDER, FDA
Related Interest Area(s): RA, SP, PM
FORMAT: FORUM
Room 121ab
Partnering for Impact in Global Health
CHAIRPERSON
Nicole Bates, DrPH
Senior Program Officer, Global Health Policy and Advocacy, Bill and Melinda
Gates Foundation
88
Wednesday, June 27
10:00 AM–11:30 AM
LEVEL: ■
CLINICAL RESEARCH
Related Interest Area(s): RA, MC
FORMAT: SESSION
Related Interest Area(s): IT, CR, QAQC
FORMAT: SESSION
Room 113b
Pharmacy
FDA Enforcement Update: Advertising and
Promotion
10:00 AM–11:30 AM
CHAIRPERSON
CHAIRPERSON
Wayne L. Pines
President, Regulatory Services and Healthcare, APCO Worldwide Inc.
Jay B. Smith, MBA
FDA enforcement actions need to be understood by every company
because they reflect FDA’s priorities and concerns in regulating advertising
and promotion. In this session, FDA professionals will examine the latest
agency enforcement actions and what they mean.
This session will provide an overview of several new identity management
technologies, standards, and practices, as used in software developed for
the clinical market. Best practices for each new method or technology will
be described, as well as how each might be used in software or clinical
development to improve efficiencies and raise quality.
Room 103b
Identity Management Technologies in Clinical Trials
CDER Point of View
Integrating a SAML Based Federated Identity Management System
for Cancer Clinical Trials at Cancer Trials Support Unit (CTSU) of
National Cancer Institute (NCI)
Ravi Rajaram, MS, PMP
Assistant Project Director, CTSU, Westat
CBER Point of View
Lisa L. Stockbridge, PhD
Branch Chief, Advertising and Promotional Labeling Branch, CBER, FDA
Who Are You … Really? Enabling Inter-organizational Researcher
Collaboration Using Federated Identity Management
Kevin Swank, MS, PMP
Lead IT Analyst/Programmer, BioInformatics Systems Unit, Mayo Clinic
COMMUNICATIONS
10:00 AM–11:30 AM
LEVEL: ■
CME and Nursing
Related Interest Area(s): MW, DM, RA
LEVEL: ◆
FORMAT: SESSION
CME and Nursing
Approaches to Identity Management Used in Clinical Trials
Jay B. Smith, MBA
Room 108b
Efficient Regulatory Medical Writing for Global
Submissions Including "ICH Outlier" Authorities
CLINICAL RESEARCH
CHAIRPERSON
Justina A. Molzon, USPHS, JD, MPharm
Associate Director for International Programs, Office of the Center Director,
CDER, FDA
10:00 AM–11:30 AM
Room 103a
This session will explore global medical writers’ proven strategies for
authoring regulatory submission documents for clinical trial and marketing
applications with overlapping content being submitted virtually simultaneously to different regional authorities.
Related Interest Area(s): EC, CR, CDM
LEVEL: ■
FORMAT: SESSION
Clinical Outcome Assessments in the Evaluation of
Medical Products in Pediatrics
CHAIRPERSON
Elektra Johanna Papadopoulos, DrMed, MPH
Medical Officer, Office of New Drugs, CDER, FDA
CTA Requirements in Europe
Beate Roder, PhD
Director, PAREXEL International, Germany
This session will discuss considerations for selection and/or development of
well defined and reliable pediatric clinical outcome assessment tools.
Opportunities for Optimization
Carlos Dufeu, RPh
Regulatory Manager, Pfizer Inc, Chile
A Regulatory Viewpoint
Carla L. Epps, DrMed, MPH
Medical Officer, Division of Gastroenterology and Inborn Errors
Products, CDER, FDA
Asian Markets: Clinical Requirements Beyond ICH
Frank C. Hubbard, PhD
Group Manager, Scientific Communications, Astrazeneca
Pharmaceuticals LP
Developing Parent Observer Reports in Infants and Young Children
Donald L. Patrick, PhD, MPH
Professor, Health Services, School of Public Health, University of
Washington
89
Wednesday, June 27
10:00 AM–11:30 AM
LEVEL: ■
FORMAT: SESSION
10:00 AM–11:30 AM
LEVEL: ■
FORMAT: FORUM
Room 119a
Building the Benefit-risk Toolbox: Is There
a Consensus on a Scientifically Acceptable
Framework?
Room 120bc
Pursuing Standards to Enhance eCTD Deliverables:
PhRMA Electronic Regulatory Submissions (ERS)
Group Annual Update
CHAIRPERSON
CHAIRPERSON
Stuart Walker, PhD
Founder, Centre For Innovation In Regulatory Science (CIRS), UK
John W. Kiser, MSc
Senior Director, Global Pharmaceutical Regulatory Affairs Operations, Abbott
Laboratories
This session will review the current perspectives from ongoing initiatives to
develop benefit-risk methodologies, examine the tool box of methodologies
from the regulators and industry perspective, and discuss if stakeholders
can agree on a general scientifically accepted framework.
The PhRMA Electronic Regulatory Submissions group presents their annual
progress report on the hottest key subteams involved in the pursuit of standards to facilitate efficient and effective electronic submissions.
The Current Status of Benefit-risk Assessment Within Agencies and
Companies: A Major Survey
Neil McAuslane, PhD, MSc
Director, Centre For Innovation In Regulatory Science (CIRS), UK
Regulated Product Submission: Progress and Status of the New
Standard
Joseph A. Cipollina, MSc
Director, eStrategy Liaison, Bristol-Myers Squibb Company
A Pilot Study Using a Shared Framework by the TGA, Health Canada,
Swissmedic, and HSA in Singapore
Jason Ferla, MD, MPH
Director, Office of Medicines Authorisation, Therapeutic Goods
Administration (TGA), Australia
Proposed PDUFA V Data Standards and IT Commitments Through 2017
Steven T. Ward
Director/Advisor, IT Strategy, Eli Lilly and Company
Electronic Submission Efficiencies: Bookmarking and Hypertext
Linking
Michelle Charles
Submissions Development Lead, Merck & Co., Inc.
The Outcome of a Pilot Study Across a Number of Companies Using
the BRAT (Benefit-risk Action Team) Methodology for Benefit-risk
Assessment
Rebecca A. Noel, DrPH, MPH
Research Scientist, Global Patient Safety, Eli Lilly and Company
10:00 AM–11:30 AM
10:00 AM–11:30 AM
LEVEL: ●
FORMAT: SYMPOSIUM
CME and Nursing
Room 118c
Current Advancement of Regulatory Reform for
Medical Devices in Asia Pacific and Its Strategic
Impact
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Room 119b
Global Product Development: Resolving
Conflicting Scientific and Regulatory Advice from
Multiple Health Authorities
CHAIRPERSON
Director, Division of Resource Development, Center for Drug Evaluation, Taiwan
CHAIRPERSON
The symposium will discuss the current advancement of regulatory pathway,
the reform of related regulations, and the impact on industry. The harmonization effort initiated by Global Harmonization Task Force (GHTF), Asian
Harmonization Working Party (AHWP), and the Regional Harmonization
Steering Committee of APEC Life Science Forum will be discussed.
Experience will be shared from industrial and regulatory perspectives.
Shannon P. Strom, PhD, RAC
Associate Director, Regulatory Affairs, Pearl Therapeutics, Inc.
When a company seeks regulatory or scientific advice from multiple health
authorities, the regulators can provide divergent recommendations. This
session will discuss strategies to resolve differing feedback and develop a
global development strategy.
Regulatory Convergence of Medical Device by GHTF/AHWP in
Asian Pacific Region
Mike D. Ward
Manager, International Programs Division, Health Canada
Agency Advice: Getting the Most From Your Meetings
Jamie Lynn Gault
Senior Director, Regulatory Affairs, Aptiv Solutions
Conflicting Scientific and Regulatory Advice: An EU Perspective
Stephen Thompson, PhD
Director, Regulatory Affairs, S-Cubed, Ltd., UK
The Recent Reform on the Taiwanese Regulatory Structure of
Medical Devices
Hsien-Yi Lin, PhD
Senior Reviewer, Division of Medical Devices and Cosmetics, Food and
Drug Administration, Department of Health, Executive Yuan, Taiwan
Conflicting Advice From Regulatory Authorities on Endpoints for
Pivotal Trials: Moving Beyond Harmonization
Cynthia J. Girman, DrPH
Senior Director, Epidemiology, Merck Research Laboratories
Medical Device Clinical Trials in China: A Proposed Strategic
Regulatory and Clinical Trial Model
Alan J. Touch
Principal Stategist, Medical Devices and In-vitro Diagnostics, INC
Research, Inc.
90
Wednesday, June 27
10:00 AM–11:30 AM
PHARMACOVIGILANCE
FORMAT: SESSION
LEVEL: ■
10:00 AM–11:30 AM
Related Interest Area(s): CR, RA, RD
FORMAT: SESSION
LEVEL: ■
Room 113c
Meeting the Therapeutic Needs of Older Patients:
A Sustainable Collaborative Approach
Room 115c
REMS: Are Our Written Communications Truly
Mitigating Risks to Patients?
CHAIRPERSON
CHAIRPERSON
Susanna Del Signore, MD
Associate Vice President, Global Regulatory Affairs, Sanofi, France
Regulators will discuss how to facilitate the implementation of affordable
development programs for unmet therapeutic needs of older patients, in
line with the existing regulatory guidance for geriatric medicines.
This session will discuss and present information on which REMS communication tools have actually been shown to positively influence prescriber
and patient knowledge and behaviors leading to mitigation of product risk
in patients. Published papers on past communication effectiveness will be
reviewed. The importance of what and how a communication is written
will be discussed for effective communication practices. New innovative
approaches to communication beyond paper information leaflets will
be presented.
PMDA Perspective on Data Evaluation of Drugs Used in Geriatric
Population
Yasuko Asahina, PhD
Researcher, Office of Regulatory Science, Pharmaceuticals and Medical
Devices Agency (PMDA), Japan
Do Written Communications Mitigate Patient Risk? A Review of the
Published Literature
EMA Geriatric Strategy
Francesca Cerreta, PharmD, MPharm, MS
Scientific Administrator, European Medicines Agency, European Union
New Approach to Geriatric Syndromes
Luigi Ferrucci, MD, PhD
Senior Investigator, Scientific Administrator, National Institute of Aging, NIH
Role of Medical Information Contact Centers in Optimizing Safe
Outcomes for Patients
Herbert B. Lee, PharmD, MBA
President, Medcom Solutions LLC
Panelist
Yoshiaki Uyama, PhD
Director, Division of Regulatory Science Research, Office of Regulatory
Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Risk and Benefit Communication: An Evidence-based Guide to
Effective Messaging
Kala L. Paul, MD, MS
President, The Corvallis Group LLC
10:00 AM–11:30 AM
LEVEL: ■
Pharmacy
Related Interest Area(s): CMC, MF, RA
FORMAT: FORUM
PHARMACOVIGILANCE
Room 122b
Regulatory Updates on Current Trends in Drug
Quality and Manufacturing
10:00 AM–11:30 AM
LEVEL: ●
Related Interest Area(s): OS
FORMAT: SYMPOSIUM
Room 118a
The Out-Sourcing/In-Sourcing/Out-Sourcing Model
for Pharmacovigilance
CHAIRPERSON
Steven Lynn, MSc
Director (acting), Office of Manufacturing and Product Quality, Office of
CHAIRPERSON
This session will attempt to link regulatory and scientific aspects related
to pharmaceutical quality issues occuring in manufacturing. A regulatory
update will be provided on recent compliance actions related to product
recalls and drug shortages. Industry speakers will follow, discussing how
scientific understanding and manufacturing controls can help mitigate risks
to product quality in the future.
Graeme A. Ladds, PhD
Director, PharSafer Associates Ltd., UK
The symposium will focus upon how to set up an outsourcing model that
allows client oversight and future flexibility to in-source at a point in the
future. Such a system can also be left open such that in times of need there
is remaining flexibility once in-sourced to immediately out-source some
aspects if the need arises. This will be a case study showing the scope, plan
for transition, and what items to leave open for ensuring adaptability once
in-sourced.
FDA Point of View
Steven Lynn, MSc
Director (acting), Office of Manufacturing and Product Quality, Office of
The Out-In-Out Sourcing Model of Pharmacovigilance
Graeme A. Ladds, PhD
Director, PharSafer Associates Ltd., UK
Detection and Mitigation of 2, 4, 6-Tribromoanisole and 2, 4,
6-Trichloroanisole Taints and Odors in the Pharmaceutical and
Consumer Health Care Industries
Anil Sawant, PhD
Vice President, Regulatory Compliance, Johnson & Johnson Consumer
Companies, Inc.
Outsourcing Pharmacovigilance, Know What You Need and How To
Get It
Martin VanTrieste
Vice President, Quality, Commercial Operations, Amgen Inc.
91
Wednesday, June 27
THINKING
10:00 AM–11:30 AM
10:00 AM–11:30 AM
Related Interest Area(s): CP, DM, MW
LEVEL: ■
FORMAT: SESSION
CME and Nursing
FORMAT: SESSION
LEVEL: ■
Room 111ab
Natural History Studies for Rare Diseases and
Orphan Conditions
Room 113a
From Adverse Events to Adverse Drug Reactions:
Statistical Issues in Safety Labeling
CHAIRPERSON
Andreas Brueckner
Principal Statistician, Bayer Pharma AG, Germany
Annette Stemhagen, DrPH, FISPE
Senior Vice President, Safety, Epidemiology, Registries and Risk
Management, United BioSource Corporation
This session will highlight statistical issues that arise during this review process, discussing approaches for screening, identification, quantification and
presentation of individual adverse drug reactions for drug safety labeling.
This session presents an overview of the design, conduct, and benefits of
natural history studies of rare diseases and orphan conditions from varied
perspectives of researchers, patients and a regulatory agency.
CHAIRPERSON
Overview of Strategies and Study Designs to Evaluate Rare Diseases
and Orphan Conditions
Annette Stemhagen, DrPH, FISPE
Senior Vice President, Safety, Epidemiology, Registries and Risk
Management, United BioSource Corporation
Data Consolidation for Labeling: Statistical Considerations
Conny Berlin, MS
Statistical Fellow, Novartis Pharma AG, Switzerland
Cumulative Meta-analyses of Clinical Trial Safety Data: Issues in
Interpretation and Dissemination
Ed Whalen, PhD
Director, Biostatistics, Pfizer Inc
Longitudinal Studies of Patients with Rare Diseases and
Opportunities for Drug Development
Anne R. Pariser, MD
Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Regulatory Perspective on Statistical Issues in Product Labeling
LaRee A. Tracy, PhD, MA
Statistical Team Leader, Office of Biostatistics, CDER, FDA
Case Study from the Rare Diseases Clinical Research Network
(RDCRN) Urea Cycle Disorder Consortium
Marshall Summar, MD
Chief, Genetics and Metabolism, Childrens National Medical Center
10:00 AM–11:30 AM
LEVEL: ●
FORMAT: SYMPOSIUM
11:30 AM–1:30 PM
Room 117
Employee Engagement
LUNCHEON
Exhibit Hall
CHAIRPERSON
Cathryn L. Anderson
Independent Consultant
Throughout the biopharmaceutical industry, employee engagement has
become an integral part of organizational strategies to develop and retain
talent. This symposium will present three types of engagement that can
contribute to increased professional satisfaction and performance.
1:30 PM–3:00 PM
Related Interest Area(s): CR, ST, CDM
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Room 109ab
Clinical, Statistical, and Data Management
Considerations for Developing Clinical Trial
Protocols
Communication and Meeting Management in the World of the
Remote Office
Cathryn L. Anderson
Independent Consultant
CHAIRPERSON
Suresh R. Siddhanti, PhD
Development Clinical Director, Amgen Inc.
Job Insurance through Networking
Bridgid Nelson
Executive Recruiter, Liberty Consulting Group
Experts from FDA and industry will provide insights on the key aspects
of developing a phase 3 clinical trial protocol. They will also discuss the
impact of standardization of data collection terminology during the clinical
development program.
Is Employee Engagement Part of Your Company's Culture? Staff
Retention Strategies for Creating Highly Functioning Teams
Gary M. Bufferd
Associate Director, Clinical Client Liaison, RPS (ReSearch
Pharmaceutical Services, Inc.)
From Drug Approval to Clinical Trial: Reverse Engineering a Drug
Approval
Robert Kane, MD
Director, Division of Oncology Drug Products, CDER, FDA
Clinical Trials in the 21st Century: How Your Data Can Survive and
How You Can Survive Your Data
Sylvia Engelen, MSc
Director, Head Clinical Statistics, US, Bayer Healthcare Pharmaceuticals
Key Success Factors in Protocol Design: Clinical/Development
Perspective
Sunil Gupta, MD, FRCPC
Associate Vice President, Sanofi Oncology
92
Wednesday, June 27
1:30 PM–3:00 PM
#350 TRACK 02 – PROJECT/PORTFOLIO MANAGEMENT AND
STRATEGIC PLANNING
LEVEL: ■
FORMAT: SESSION
CME and Nursing
1:30 PM–3:00 PM
Room 108a
New Regulations and Guidance for Clinical Trials
and Human Subject Protection
LEVEL: ■
PMI PDUs
Related Interest Area(s): PM, OS, SP
FORMAT: SESSION
Room 103c
Drug Development Strategies and Incorporation of
an Established Project Management System
CHAIRPERSON
Cynthia M. Gates, JD, RN
Vice President, Education and Consulting Services, Western Institutional
Review Board
CHAIRPERSON
This session will cover recent changes to regulations and guidances as well
as proposed changes by the Office for Human Research Protections (OHRP)
and FDA. Attendees will learn how the changes might affect their day-to-day
workflow, how to identify compliance gaps and how to correct the gaps.
This session will look at strategic planning as a foundation upon which a
drug development program defines the tasks that need to be completed,
when they must be completed, the associate cost, the key personnel and
use of established PM system.
Marija Ribar, DMD, MBA
Director, Product Development Consultancy, Aptiv Solutions
New US Regulations and Guidance for Clinical Trials
Cynthia M. Gates, JD, RN
Vice President, Education and Consulting Services, Western Institutional
Review Board
Designing and Implementing a Drug Planning Framework
Peter Harpum, PhD, MSc
Managing Director, Harpum Consulting Ltd., UK
Cross-function Project Management for an Initial IND: CMC
Perspective
Alexander D. Smith
General Manager, ADS Pharma Consulting, LLC
New US Regulations and Guidance for Clinical Trial Billing
Michael C. Roach, JD
Partner, Meade and Roach, LLP
New Regulations and Guidance for Conducting Clinical Trials Outside
of the US
Nancy Meyerson-Hess, MSc
Compound Development and Branding, Gruenenthal, Germany
Integrated Drug Development: Case Study
Marija Ribar, DMD, MBA
Director, Product Development Consultancy, Aptiv Solutions
1:30 PM–3:00 PM
Related Interest Area(s): CR, PM, SP
LEVEL: ■
FORMAT: SESSION
CME and Nursing
1:30 PM–3:00 PM
Room 105ab
Building Clinical Site Capacity for Research
LEVEL: ●
PMI PDUs
Related Interest Area(s): SP, OS, CR
FORMAT: SESSION
Room 111ab
Thinking Small! A Virtual Pharma Gets Big Work
Done with Like-minded Partners
CHAIRPERSON
Peggy L. Coyle, MS, RN
Senior Manager, Clinical Research Team, FHI 360
CHAIRPERSON
Jean A. Hendrickson
Vice President, Novella Clinical Inc.
The South East Asia Infectious Disease Clinical Research Network
(SEAICRN), a collaborative partnership of hospitals and institutions in
Thailand, Vietnam, Indonesia, and Singapore, embarked on a significant
clinical research capacity building effort. Its key objective was to establish
an experienced clinical research team comprising doctors, nurses, study
coordinators, research pharmacists, lab technicians, data management and
administrative personnel. To support this effort, the SEAICRN developed a
new model for clinical trials support through the establishment of local clinical trials support specialists (CTSS). This session will present experiences
with this new model and show how it can be applied successfully, as well as
describe a capacity development project for a local ethics committee.
This informative session will provide attendees with a unique case study
highlighting an innovative, collaborative, and dynamic partnering model
that is distinctive as compared to traditional outsourcing methods.
Lisa Zimmerman, MS
Vice President, Clinical Operations, POZEN, Inc.
Jean A. Hendrickson
Vice President, Novella Clinical Inc.
Developing Site Capacity for International Research: US Government
Strategies
Christian P. Yoder, MPH, RN
Clinical Research Specialist, National Institute of Allergy and Infectious
Disease, National Institutes of Health
1:30 PM–3:00 PM
LEVEL: ■
PMI PDUs
Related Interest Area(s): OS, FI, CR
FORMAT: SYMPOSIUM
Room 118a
Functional Service Provider Symposium
A Real Life Example: Developing Site Capacity in Southeast Asia
Julia D. Welch, MS
Senior Clinical Project Manager, Clinical Monitoring Research Program,
SAIC-Frederick, Inc.
CHAIRPERSON
Susan Torchio, BSN, RN
Global Clinical Operation Lead for Cardiovascular/Immunology/Inflammation,
Teva Pharmaceuticals
Translating the Model: On the Ground Experience in Vietnam
Peggy L. Coyle, MS, RN
Senior Manager, Clinical Research Team, FHI 360
There are many ways to partner with a functional service provider (FSP).
This symposium will provide case studies of how several of these models
93
Wednesday, June 27
Companies are increasingly looking for consistency in marketing campaigns
across the globe. This raises challenges for the advertising/promotion
review process in determining appropriate company review standards and
finding efficient ways to achieve regulatory approval of promotional materials. This session will discuss how to remain compliant in the international
marketing arena.
have worked and how the appropriate model was selected, as well as
discuss performance metrics/key performance indicators (KPIs) and governance and infrastructure of the various models. Pricing strategies including
unit costing, cost savings and risk sharing, will also be explored.
Functional Service Provider Partnering: Choosing the Right Model to
Achieve Strategic Success
Ian Birks
Vice President, Global Functional Resourcing, Quintiles
Jose Zamarriego, MBA
Head Code of Practice Surveillance Unit, Farmaindustria, Spain
Heather Simmonds
Director, Prescription Medicines Code of Practice Authority (PMCPA), UK
Implementing Unit Pricing in Strategic Functional Service Provider
(FSP) Relationships
Anne Marie L. Inglis, PhD
Director, US Clinical Operations, Biologicals, GlaxoSmithKline
Ray Chepesiuk, MBA, RPh
Commissioner, Pharmaceutical Advertising Advisory Board (PAAB),
Canada
Strategic Partnering to Enhance Timelines Through Resource
Management and KPI Risk Sharing
Jennifer Charron
Director, Embedded Clinical Programs, RPS (ReSearch Pharmaceutical
Services, Inc.)
#355 TRACK 06A – MEDICAL WRITING AND MEDICAL
COMMUNICATIONS
1:30 PM–3:00 PM
Room 124
1:30 PM–3:00 PM
Related Interest Area(s): PC, NC, CDM
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Room 108b
Global Medical Information in Real-life Situations
Microdosing: Past Experience and Future Role in
Translational Medicine
CHAIRPERSON
Lillian Auberson, PhD
Senior Director, Head of Global Medical Information, Actelion
Pharmaceuticals Ltd, Switzerland
CHAIRPERSON
Tal Burt, MD
Scientific Director, Duke Global Proof-of-Concept Research Network, Duke
Clinical Research Institute
It is easy to resonate with the vision and goals of a globalized medical
information service which enables a pharmaceutical company to speak
with one voice with its customers. In most models for a globalized service,
workflows and tools are put in place for streamlining information gathering and dissemination. Stewardship for the content of medical information response documents is provided by a global team, operating under
internal governance for content development and appropriate information
disclosure. This session will explore the resiliency and vulnerability of global
medical information services in real-life situations.
Microdosing holds the promise of increasing drug selection efficiency
through the introduction of subpharmacological doses of test articles to
humans. The session examines existing data, potential applications and
future role of microdosing.
Microdosing: Past and Future
Graham Lappin, PhD
Chief Scientific Officer, Xceleron Ltd., UK
International Medical Information Service: Can We All Speak the
Same Language?
Robert M. Winslow, PharmD
Global Director, Medical Information Services, Lifecycle Safety, Quintiles
PET-Microdosing: Unique Capabilities, Challenges, and
Opportunities for Drug Development
Martin Bauer, MD
Research Associate, Department of Clinical Pharmacology, Medical
University of Vienna, Austria
Global Medical Information Teams: Working Together to Deliver
Results
Purnima J. Topiwala, PharmD
Associate Director, Medical Information, Janssen Scientific Affairs, LLC
Use of Microdosing in Drug Development: Is the Evidence Convincing?
Joseph S. Bertino, Jr., PharmD
Principal, Bertino Consulting
Global Medical Information in Times of Transition
David Ryan Perkins, RPh
Global Vice President, Medical Information, Genzyme Corporation
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): MC, DM, OS
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Panelist
J.C. Muyl, MA
Executive Vice President, C3i, Inc.
Related Interest Area(s): MC, MA
FORMAT: SESSION
Room 113b
Pharmacy
CHAIRPERSON
Thomas M. Casola, MBA
Vice President, Global Regulatory Affairs, Advertising, Promotion & Labeling,
Shire Specialty Pharmaceuticals
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#356 TRACK 06B – MEDICAL WRITING AND MEDICAL
COMMUNICATIONS
CLINICAL RESEARCH
Related Interest Area(s): CP, CDM
1:30 PM–3:00 PM
LEVEL: ■
FORMAT: WORKSHOP
1:30 PM–3:00 PM
LEVEL: ■
Related Interest Area(s): CDM, IT, VA
FORMAT: FORUM
Room 121c
What Medical Writers Need to Know about
MedDRA®
Room 103b
Business Applications in the Cloud
CHAIRPERSON
Venkatesan Thangaraj
Radiant Sage, LLC
CHAIRPERSON
Patricia Mozzicato, MD
Chief Medical Officer, MedDRA® MSSO
This session will address how cloud technology is applied to specific business needs.
This workshop will present ways for medical writers to avoid missteps
in interpreting safety data and optimize presentation and analysis of
MedDRA® data. Exercises highlighting MedDRA's features and ICH "Points
to Consider" principles will be given.
Cloud Based Medical Image Management in Clinical Trials
Kris Kokomoor, MSc
Associate Director, Clinical Informatics and Innovation, Pfizer Inc
Cloud Services for 21st Century WHO DRUG Coding and Best
Practices
Ola Strandberg, MSc
Vendor Liasion Officer, The Uppsala Monitoring Centre, Sweden
Moderator
Judy E. Harrison, MD
Senior Medical Officer, MedDRA® MSSO
Conceptual Model of the Use of Tablets and Cloud Services to
Conduct a Clinical Trial
David Plante, MS
Director, Information Technology, Aegerion Pharmaceuticals, Inc.
CLINICAL RESEARCH
1:30 PM–3:00 PM
Related Interest Area(s): IT, CDM, MC
LEVEL: ●
FORMAT: SESSION
1:30 PM–3:00 PM
Room 103a
Innovations Aimed at Improving Effectiveness and
Speed of the Therapeutic Development Process
FORMAT: SESSION
LEVEL: ■
Room 120bc
Orphan Drug Development: Global Regulatory
Challenges and Initiatives
CHAIRPERSON
CHAIRPERSON
Alexander Fleming, MD
President and Chief Operating Officer, Kinexum
Kinnari Patel, PharmD
Associate Director, Global Regulatory Sciences, Bristol-Myers Squibb
Company
Three complementary innovations will be presented in an interactive discussion with a senior FDA official and the audience. The connecting thread
is addressing unmet need and improving clinical outcomes by applying
maturing science, new technologies, and partnerships to the therapeutic
development and evaluation processes.
This session will focus on critical need for developing orphan drugs, review
of global orphan drug development challenges, and provide information on
various strategies designed to overcome these challenges.
Summary of NORD Activities/Initiatives
Timothy R. Cote, MD, MPH
National Organization For Rare Disorders (NORD)
Innovative Use of People, Process, and Technology to Execute Riskbased Monitoring
Margaret M. Keegan
Global Head, Integrated Processes and Technologies, Quintiles
Regulatory Challenges and Initiatives: Strategies for Success
Jonca C. Bull, MD
Vice President, Drug Regulatory Affairs, FDA Liaison Office, Novartis
Pharmaceuticals Corporation
Data Collection for Companion Diagnostics in Clinical Trials
Cari Deloa
Senior Data Manager, Genentech, Inc.
Obtaining Orphan Product Development: Challenges and Pitfalls
Marlene E. Haffner, MD, MPH
President and CEO, Haffner Associates, LLC
FDA Point of View
95
Wednesday, June 27
1:30 PM–3:00 PM
LEVEL: ●
FORMAT: SESSION
CME and Nursing
1:30 PM–3:00 PM
Room 119b
Operationalizing SDTM
Deputy Director, Office of Business Informatics, CDER, FDA
CHAIRPERSON
Joseph A. DiMasi, PhD
Director, Economic Analysis, Tufts Center for the Study of Drug
This session will provide practical advice and feedback to industry regarding submission of CDISC SDTM data to CDER and CBER. The session should
allow sponsors to gain answers to common questions and issues that arise
with SDTM submitted to FDA.
The implications of industry practices and public policies for R&D productivity and the incentives to innovate will be examined.
Douglas L. Warfield, PhD
Regulatory Information Specialist, Office of Business Informatics,
CDER, FDA
Trends in the Economics of New Drug and Biologics Development
Joseph A. DiMasi, PhD
Director, Economic Analysis, Tufts Center for the Study of Drug
Dhananjay R. Chhatre, MS, RAC
Operations Research Analyst, Office of Business Informatics, CDER, FDA
Challenges and Opportunities in Biotechnology
Raymond G. Starrett, MS
Senior Director, Project Management, Targacept Inc.
Amy Malla, MT, PMP
Consumer Safety Officer, Office of the Director, CBER, FDA
Emerging US Biosimilar Policy
Kathleen Basmadjian, PhD, MSc
Senior Director, Global Regulatory Policy and Intelligence, Janssen
Research & Development, LLC
LEVEL: ■
Related Interest Area(s): RD, BT
FORMAT: SESSION
Room 113c
Emerging Development and Policy Trends in the
Economics of the Biopharmaceutical Industry
CHAIRPERSON
1:30 PM–3:00 PM
LEVEL: ●
Pharmacy
Related Interest Area(s): RA, PPLCC
FORMAT: SYMPOSIUM
Room 118c
Update on Revision of European Medical Device
Directives and Impact on Industry
CHAIRPERSON
Shayesteh Fuerst-Ladani, MBA, MS
Director, SFL Regulatory Affairs and Scientific Communication, Switzerland
1:30 PM–3:00 PM
This symposium will provide an overview of the latest development and
EU Commission's proposals on the Revision of Medical Device Directives
including In-Vitro Diagnostics Directive in comparison to the current legislation will be provided. Notified Body representative will analyze the impact
of the revised legislation will have on the system of third party assessment
in Europe; and highlight those elements changed in the supervision by the
third parties on industry and other stakeholders as consequence of the
revised legislation. Further, the impact of the revised legislation on the company procedures and strategy will be provided. Additionally, an overview
on the current and future reporting of serious adverse events from medical
device trials in Europe will be provided.
Room 121ab
LEVEL: ■
Pharmacy
Related Interest Area(s): GCP, CR, EC
FORMAT: SYMPOSIUM
The Changing Face of Clinical Compliance:
Regulatory, Technology, and Services
CHAIRPERSON
Penelope Przekop, MSc
Senior Director, Global Quality Assurance and Training, Theradex Systems
The face of clinical compliance is changing based on regulatory and
technological advances. Long accepted industry standard practices require
change. These changes are impacting pharmaceutical companies as well as
their service providers. Quality professionals are key partners for ensuring
that appropriate industry changes continue to reflect current regulations
and protect patient safety. This symposium features clinical quality assurance experts who will address one of these key aspects of our changing
environment: regulatory, technology, and service.
An Overview on the Revision of the EU Medical Device Directives
Including In-Vitro Diagnostics
Shayesteh Fuerst-Ladani, MBA, MS
Director, SFL Regulatory Affairs and Scientific Communication,
Switzerland
GCP Audit Implications of the New Clinical Monitoring Guidance
Document
Carol Bognar, MSN, RN
QA Consultant, Carol Bognar Consulting, LLC
Notified Body View on EU Revision of Medical Device Legislation
Ibim B. Tariah
Technical Director, Healthcare, BSI
A Whole New World: CRO Clinical Quality Assurance
Penelope Przekop, MSc
Senior Director, Global Quality Assurance and Training, Theradex
Systems
The Impact of the EU Medical Devices Directives' Revision on
Company Procedures and Strategy
Sunita Prem Ahir, PhD, MSc, RAC
Regulatory Affairs Manager, D-Target, a Premier Research Company,
Switzerland
The Role of Quality Assurance in eClinical Environments — When to
Dive in
Shiela McLaughlin
International Director, Quality Assurance, DATATRAK International
Current and Future Reporting of Serious Adverse Events from
Medical Device Trials in Europe
Regina Freunscht
Director, Marketing and Communications, Accovion GmbH, Germany
96
Wednesday, June 27
1:30 PM–3:00 PM
LEVEL: ●
PHARMACOVIGILANCE
Related Interest Area(s): CM, MF, CP
FORMAT: WORKSHOP
1:30 PM–3:00 PM
Room 123
Quality Risk Management Workshop
Room 115c
Data Sources for Monitoring Usage of Drug
Products and How to Use These Sources to
Support Safety and REMS Evaluations
CHAIRPERSON
Fritz Erni, DrSc
Consultant, Switzerland
CHAIRPERSON
This interactive workshop will give a brief overview of simple quality risk
management (QRM) tools. In small groups, participants will work with common QRM tools such as Process Maps, Fishbone Diagrams and Failure Mode
Effects Analysis (FMEA) to determine product critical quality attributes and
critical process steps for a simple manufacturing process.
Juliane Mills
United Biosource Corporation
This forum will present several options for monitoring opioid drug usage
within the US and discuss ways to incorporate these monitoring sources to
support safety and REMS evaluations.
be recorded.
RADARS® System: Mosaic Approach to Opioid Surveillance & REMS
Evaluation
Jody L. Green, PhD
Director of Research Administration, Denver Health, Rocky Mountain
Poison & Drug Center
Moderators
Celia N. Cruz, PhD
Chemist, Office of New Drug Quality Assessment, Office of
Pharmaceutical Science, CDER, FDA
Real-time Data Streams and Their Potential Utility in REMS
Assessment
Kevin Zacharoff, MD
Vice President, Medical Affairs, Inflexxion, Inc.
THINKING
1:30 PM–3:00 PM
Room 107ab
Related Interest Area(s): CDM, RA, CR
FORMAT: FORUM
LEVEL: ●
1:30 PM–3:00 PM
LEVEL: ■
FORMAT: SESSION
Room 113a
Impact of Bayesian Methods in Medical Product
Development
Related Interest Area(s): PR, RA, PPLCC
LEVEL: ■
FORMAT: SYMPOSIUM
CHAIRPERSON
The Use of Health Technology Assessment (HTA)
for Access and Resource Allocation Decision
Making: International Examples
Karen Lynn Price, PhD, MA
Principal Research Scientist, Eli Lilly and Company
Bayesian methods play an important role throughout the medical product
development process. The DIA Bayesian Scientific Working Group, a coordinated effort from academia, regulatory, and industry, helps ensure that
methods are well understood, accepted, and utilized.
CHAIRPERSON
Outcomes Liaison, Eli Lilly and Company
To maximize the value of medicines while managing limited medical resources, many national and private insurers are applying a Health
Technology Assessment (HTA) as a support for the decision-making
process. This symposium will cover the use of HTA in three international
examples, including discussions of comparative effectiveness analysis, managed entry agreements, and risk share agreements.
An Overview of Bayesian Evidence Synthesis Techniques with
Applications in Safety Evaluation and Comparative Effectiveness
David Ohlssen, PhD
Senior Expert Methodologist, Novartis Pharmaceuticals Corporation
The Use of Subjective Priors in Drug Development
Nelson M. Kinnersley, MSc
Associate Director, Biostatistics, Roche Products ltd, UK
Access to Innovation and HTAs Enforced by Managed Entry
Agreements in Combination with Treatment Registers
Luca De Nigro, MS
Coordinator, Drugs Monitoring Register, Italian Medicines Agency
(AIFA), Italy
Bayesian Approaches for Data Mining for Spontaneous Adverse Events
Ram Tiwari, PhD
Associate Director for Statistics, Office of Biostatistics, Office of
HTA Application for Medical Resources Allocation in National Health
Insurance Scheme: A Case Study for Osteoporosis in Taiwan
Comparative Effectiveness Research: Impact and Need for Risk
Share Agreements
Stephen J. Clark
Vice President, Market Access and Value Strategy, OptumInsight
97
Wednesday, June 27
1:30 PM–3:00 PM
The Power of Patient-driven Research and Rare Disease Online
Communities: The SCAD Ladies and Beyond
Brian Loew
CEO, Inspire
FORMAT: SESSION
CME and Nursing
LEVEL: ■
Room 122b
Pharmaceuticals and Medical Devices Agency
(PMDA) Town Hall
Biopharma and Social Media: A Case Study
Eric Grinstead
Senior Vice President, Commercial Operations, Synageva Biopharma
Corporation
CHAIRPERSON
Toshiyoshi Tominaga, PhD
Office Director, Office of International Programs, Pharmaceuticals and
PMDA will explain its current services and the Japanese drug regulation and
answer your questions on these and PMDA's future initiatives/challenges for
faster review and better life cycle management of drugs.
1:30 PM–3:00 PM
CHAIRPERSON
Corey B. Dunham
Senior Vice President, Global Data Management, Aptiv Solutions
Hideo Utsumi, PhD
Executive Director and Director, Center for Product Evaluation,
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Although adaptive design concepts have been available for some time,
only recently has implementation been achievable. This breakthrough
is possible because of the development of integrated technologies and
operational processes specifically designed to support the execution of
adaptive trials.
Kenichi Tamiya
Deputy Director, Research and Development Division, Health Policy
Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Brought to you by Aptiv Solutions.
staff member.
Room 119a
CBER Town Hall
Related Interest Area(s): ST, CR, EC
Format: SESSION
Room 125
Implementation of Adaptive Clinical Trials
Tatsuya Kondo, MD, PhD
Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA),
Japan
1:30 PM–3:00 PM
LEVEL: ●
FORMAT: FORUM
Judith A. Quinlan, MSc
Senior Vice President, Adaptive Trial Design Implementation,
Aptiv Solutions
LEVEL: ●
CME and Nursing
Vladimir Dragalin, PhD
Senior Vice President, Clinical Trial Innovation Strategies,
Aptiv Solutions
CHAIRPERSON
Karen Midthun, MD
Director, CBER, FDA
This session will provide an overview of CBER’s current work on ongoing
initiatives, guidances, and regulations.
3:00 PM–3:30 PM
Robert A. Yetter, PhD
Associate Director for Review Management, Office of the Director,
CBER, FDA
Exhibit Hall
Karen Midthun, MD
Director, CBER, FDA
3:30 PM–5:00 PM
1:30 PM–3:00 PM
REFRESHMENT BREAK
LEVEL: ■
Related Interest Area(s): IS, PR, PPLCC
FORMAT: SESSION
Room 109ab
Standard of Care: Challenges for Sponsors, Sites,
and Patients in Clinical Trial Budgets
Related Interest Area(s): AP, CR
LEVEL: ■
FORMAT: FORUM
Room 115a
Social Media 2.0: The Power of Online Rare Disease
Communities to Connect and Engage ePatients
CHAIRPERSON
Sondra A. Pepe
Product Manager, Medidata Solutions Worldwide
CHAIRPERSON
A sponsor and site share methods for identifying standard of care, including case studies that express the real-world impact on sites and patients.
A novel patient survey explores the public perception of free care in the
context of clinical trials.
Julia Nable
Director of Marketing Strategy, SandorMax
Relevant case studies will be presented to demonstrate how online patient
communities and social media are revolutionizing how patients gain access
to disease and treatment information.
Prepare Budgets for Projects with Coverage Analysis
Kelly M. Willenberg, BSN, MBA
Consultant, SYNERGISM, LLC
RareConnect: A Global Social Network for Rare Disease Communities
and Patients
Tai Spargo
Assistant Director of Communications, National Organization for Rare
Disorders (NORD)
Sponsors’ Responsibilities with Coverage Analysis
Soo Y. Bang, MHA
Director, Global Site Contracts, Celgene Corporation
98
Wednesday, June 27
3:30 PM–5:00 PM
The Role of Data Visualization in Clinical Monitoring
Michael J. Brennan, PhD
Director, Informatics, Johnson & Johnson Pharmaceutical Research &
Development, LLC
Related Interest Area(s): CR, PM, IS
FORMAT: SYMPOSIUM
CME and Nursing
LEVEL: ●
Room 105ab
Special Populations Symposium
Optimizing the Monitoring Visit with Standardized Practices and
Innovative Technology
Lisa Rhiner
Clinical Study Lead, Kforce Inc., Now Part of Inventiv Health
CHAIRPERSON
Brenda Jamerson, PharmD
Associate Professor, Clinical Research, Campbell University College of
Pharmacy and Health Sciences
Recruitment and retention of a diverse population in clinical trials is
becoming increasingly important. In order to adequately address efficacy
and safety targets in specific subsets of the population, clinical trials must
include a broad range of participants across the spectrum of race, ethnicity
and age. This symposium will present practical insights for clinical trial
operational planning that optimizes recruitment and retention of Blacks,
Latinos, and geriatric participants in clinical trials.
STRATEGIC PLANNING
3:30 PM–5:00 PM
CHAIRPERSON
Eric M. Towler, PhD, PMP
Director, Global Project Management and Leadership, Daiichi Sankyo Inc.
This session will describe actual case studies of successful oncology development programs. Presenters will focus on the key success factors to a
productive collaboration and lessons learned from their own experiences.
A Winning Messaging and Media Strategy for Latino Patient
Recruitment: As Easy as Uno, Dos, Tres
Carmen R. Gonzalez, JD
Manager, Strategy and Communications, Healthcare Communications
Group, Inc.
Gaining Global Consensus on the WHAT of a Clinical Program
Anthony P. Wiemelt, DrSc, PhD
Senior Project Manager, Pipeline Leader Infectious Disease, Merck &
Co., Inc.
Special Populations: Clinical Trial Planning Considerations for
Geriatric Patients in Clinical Trials
Kelly Larrabee, MBA, MS, RN
Senior Director, Clinical Services, ClearTrial, LLC
How Innovation and Collaboration Kept Pharmaceutical Sciences Off
Critical Path to Filing
Richard S. Hutchins, PhD
Pharmaceutical Sciences Oncology Business Unit Lead, Pfizer Inc
Global Development: Towards Simultaneous Global Submissions and
Approvals
Mann Fung, MD, MBA, FACP
Compound Development Team Leader – PCI32765 and Cell Therapy
Teams, Johnson & Johnson Pharmaceutical Research & Development, LLC
Room 108a
Related Interest Area(s): PM, RA, CR
FORMAT: SESSION
Room 103c
Planning and Execution of a Global Oncology
Program
Strategies to Enhance Recruitment and Retention of Ethnically
Diverse Populations in Clinical Trials
Brenda Jamerson, PharmD
Associate Professor, Clinical Research, Campbell University College of
Pharmacy and Health Sciences
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): CR, PM, CDM
LEVEL: ■
FORMAT: SYMPOSIUM
Optimizing Study Monitoring Performance and
Efficiency
CHAIRPERSON
Tufts Center for the Study of Drug Development, Chairman, The Center for
Information and Study on Clinical Research Participation (CISCRP), Tufts
University
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): OS, PM, CR
FORMAT: FORUM
Room 111ab
PMI PDUs
Effectively Managing Global Trials Within a CRO
Alliance Structure
The global CRA workforce plays a vital role in assessing clinical trial compliance, maintaining relationships with investigative sites, monitoring patient
safety and ensuring data quality. During the past decade, study monitor
workload has increased and utilization has changed dramatically, with wide
variability by geographic region. This symposium explores key characteristics, responsibilities and capacity of the global CRA workforce, notes trends
impacting study monitor performance, and explores practices and solutions
designed to improve CRA capacity, efficiency and effectiveness.
CHAIRPERSON
Michael J. O’Brien
President, CEO, Beardsworth Consulting Group Inc.
This forum explores one key challenge confronting global alliances of
regional CROs: aligning motivations and expectations of sponsor and alliance members to achieve an optimal multicultural, multinational result.
Characterizing Global CRA Workforce Workload and Utilization
Tufts University
Global Alliance Model from Concept to Reality
Michael J. O’Brien
President, CEO, Beardsworth Consulting Group Inc.
Global Studies: Lessons and Observations from the Asia Pacific
Alek Safarian, MBA, RPh
CEO, Novotech (Australia) Pty Ltd, Australia
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Wednesday, June 27
Pharmacogenomics as a Model for Biomarker Discovery and
Translation
Deepak Voora, MD
Instructor of Medicine, Division of Cardiology; Associate Investigator,
Duke Institute for Genome Sciences and Policy
Challenges in Global Trials Management: Central and Eastern Europe
Partner Perspective
Malgorzata Szerszeniewska, MD
CEO, EastHORN Clinical Services CEE, Poland
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): CR, IS, OS
FORMAT: SYMPOSIUM
3:30 PM–5:00 PM
Related Interest Area(s): RA, MC, CP
FORMAT: SESSION
Room 113b
Pharmacy
Leveraging Drug Development and Advertising/
Promotion Regulatory Expertise to Drive a Robust
Target Product Profile Process
Room 118a
Sites, CROs, and Sponsor Relationship Obstacles
and Opportunities
CHAIRPERSON
CHAIRPERSON
Suzanne Collins, BSN
Director of Operations, Trifecta Multimedical
Michele L. Sharp, PharmD
Senior Director, Global Regulatory Affairs – US, Eli Lilly and Company
In this symposium, prerecorded interviews from site personnel will be a
backdrop for discussions on how evolving sponsor/CRO relationships have
affected sites, if the current paradigm is allowing sites to transfer their
knowledge gained during clinical trials effectively, what sites ultimately
need from the sponsor and CRO to consistently produce valuable data.
In March 2007, FDA issued a draft guidance entitled, Target Product Profile
— A Strategic Development Process Tool. This FDA Guidance could be used
to facilitate the connections between clinical planning, label statements,
and scientific communications to customers. Today, several challenges exist
in associating seamless integration of clinical development data into the
label and then into promotional communications. This expert panel will
explore ways to leverage the targeted product profile tool in your company's
drug development process maximizing both the drug development and
advertising/promotion regulatory expertise. The panel will also consider
how to effectively incorporate the targeted product profile tool into discussions with FDA.
Site, CRO, and Sponsor Communication Challenges
Suzanne Collins, BSN
Director of Operations, Trifecta Multimedical
A Boat Won’t Float Without Water: The Effect of Sponsor/CRO
Partnerships on Sites
Rikki Hansen Bouchard, MPA
President and Chief Executive Officer, RH Bouchard & Associates Inc.
FDA Point of View
CDER, FDA
Knowledge Transfer in Clinical Trials: Is the Collaboration with
Investigative Sites Utilized?
Marie Smed, MSc
PhD Student, Technical University of Denmark, Denmark
Tracy Rockney
Divisional Vice President, Abbott Laboratories
3:30 PM–5:00 PM
LEVEL: ■
Amy A. Jennings, PhD
Director, Global Regulatory Sciences, Bristol-Myers Squibb Company
Related Interest Area(s): NC, BT
LEVEL: ●
FORMAT: SESSION
CME and Nursing
Room 124
Biomarker Focused Strategies for Personalized
Medicine
COMMUNICATIONS
CHAIRPERSON
Renee Pridgen
Assistant Director, Clinical Operations, Duke Clinical Research Institute
3:30 PM–5:00 PM
Related Interest Area(s): MW, RA, ST
LEVEL: ■
FORMAT: SESSION
Room 108b
Recent Advances in Adaptive Clinical Trial Designs
for Medical Writers
Clinical care centers on standards based on epidemiological studies of large
cohorts. However, these studies do not take into account genetic variability.
This session discusses the pursuit of personalized medicine through
biomarker collection.
CHAIRPERSON
William K. Sietsema, PhD
Vice President, Regulatory Strategy, Consulting, and Submissions, INC
Research, Inc.
Cell-based Systems as Platforms to Identify Unique Biomarkers in
Drug Discovery
Kenneth J. Pennline, PhD
Vice President and Global Head, Cytometry Services, Labcorp Clinical
Trials
In this session, speakers will review the types of adaptations that can be
built into clinical trials and the types of concerns these adaptations raise
with regulators and the scientific community. Statistical methodologies will
also be reviewed.
The Role of Biobanks in Developing Better Biomarkers
E. David Litwack, PhD
AAAS Science and Technology Policy Fellow, National Cancer Institute,
National Institutes of Health
100
Wednesday, June 27
Overview of Adaptive Design Concepts and Common Types of
Adaptations
Research, Inc.
Clinical Study Setup Automation with eProtocol
Richa Singh, MPharm
Business Analyst, Cognizant Technology Solutions Corporation, India
Chain of Custody: CDASH to Data Submission
Janet Stuelpner, MA, MS
Solutions Architect, SAS Institute
Implications of Adaptive Designs for Preparation of Protocols,
Statistical Analysis Plans, Clinical Study Reports, and Elements of
Marketing Authorization Applications
Annie C. Solterbeck, PhD, MSc
Director, Statistical Revelations, Australia
Single Source SAE Data Collection via EDC in Relation to Centralized
Monitoring
Wim Verreth, DrMed, MS
SGS Life Science Services, Belgium
A Regulatory Perspective on Adaptive Designs in Drug Development
H.M. James Hung, PhD
Division Director, Office of Translational Science, CDER, FDA
3:30 PM–5:00 PM
CLINICAL RESEARCH
3:30 PM–5:00 PM
Room 103a
Related Interest Area(s): RA, CR, ST
FORMAT: SESSION
Room 119b
Adaptive Licensing: Bane or Boon for Drug
Development?
Related Interest Area(s): IT, CDM, RD
FORMAT: SESSION
LEVEL: ■
CHAIRPERSON
Sharing Clinical Data: Examples of What to Share
and Benefits to Research and Patients
Regulatory decisions are of necessity based on incomplete data. Traditional
drug licensing approaches are based on binary approval decisions which
reduce the uncertainty of an experimental therapy to a fully vetted, safe,
and efficacious market authorization. Adaptive licensing (AL) proposals
would contrast this precedent providing iterative phases of data gathering
followed by regulatory evaluation and would allow the approval process to
align more closely with patient needs such as timely access to new technology and the information required to inform medical decisions. Adaptive
licensing would build on and broaden existing elements of drug regulation,
including accelerated approval (in US) or conditional marketing authorization (in EU). This session summarizes a number of recent AL proposals and
discusses how AL might be translated into practice.
CHAIRPERSON
Michael N. Cantor, MD
Senior Director, Biomedical Informatics, Pfizer Inc
This session will highlight the importance of robust systems that promote
data sharing. Moving from the general to the specific, the session will examine strategies that promote data transparency and access, a database that
promotes data integration for biospecimens, and a database that integrates
administrative and clinical data for quality and research.
Data Without Borders: IT Strategy Enabling Research and
Development
Michael N. Cantor, MD
Senior Director, Biomedical Informatics, Pfizer Inc
Paving the Way to Adaptive Licensing
Robyn R. Lim, PhD
Scientific Advisor, Progressive Licensing Project, TPD, HPFB, Health
Canada
Italian Population-based Linked Database to Measure Health
Performance in the Real World
Marisa De Rosa
Head of Systems and Services for Health Department (SISS), CINECA
Inter-University Consortium, Italy
Panelists
Thomas Unger, PhD
Executive Director, Worldwide Regulatory Strategy, Pfizer Inc
Integrating Advanced IT Systems that Streamline Management of
Biospecimen Inventories and Associated Clinical Data
Lori Ball, MBA
Chief Operating Officer, BioStorage Technologies, Inc.
Kenneth Oye, PhD
Associate Professor, Political Science; Co-Director, Program on
Emerging Technologies, Massachusetts Institute of Technology (MIT)
CLINICAL RESEARCH
3:30 PM–5:00 PM
LEVEL: ■
3:30 PM–5:00 PM
Related Interest Area(s): CDM, EC, SUBS
LEVEL: ■
FORMAT: SYMPOSIUM
CME and Nursing
LEVEL: ◆
FORMAT: SESSION
Pharmacy
Room 120bc
Room 103b
Automation Through CDISC Standard Models:
eProtocol, Data Submission, and Safety Reporting
CHAIRPERSON
Nikhil Mehta, PhD
Vice President, Biologics, Global Regulatory Affairs, Merck & Co., Inc.
CHAIRPERSON
Richa Singh, MPharm
Business Analyst, Cognizant Technology Solutions Corporation, India
Statutory framework for biosimilars was approved in the US in March 2010.
This session will discuss progress in defining regulatory standards for
approval of biosimilars.
This symposium will include discussions on automated solutions based on
CDISC and CDASH data standard models that can bring significant effort
reduction and process optimization across the clinical data management
framework.
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Wednesday, June 27
WHO’s Goals and Priorities
Lembit Rago, MD
Coordinator, Quality Assurance and Safety for Medicines, World Health
Organization (WHO), Switzerland
Global Development of Biologics and the On-Going Need for
Regulatory Harmonization Being Applied to Biosimilars
Mark McCamish, MD, PhD
Global Head of Biopharmaceutical Development, Sandoz
Biopharmaceuticals, a Novartis Company, Germany
Sustainable Capacity Building For Regulatory Workforce in Africa
Paul K. Tanui
Senior Programme Officer, NEPAD Planning and Coordinating Agency,
South Africa
Regulatory Standards for Biosimilars: Balancing Risk and Access
Jay P. Siegel, MD
Chief Biotechnology Officer, Global Head Regulatory Affairs, Johnson
& Johnson
Panelist
Associate Director for Biosimilars, Office of New Drugs, CDER, FDA
#385 TRACK 10A – PUBLIC POLICY/HEALTH CARE
3:30 PM–5:00 PM
LEVEL: ■
Related Interest Area(s): GCP, CR, CDM
FORMAT: WORKSHOP
3:30 PM–5:00 PM
Related Interest Area(s): PPLCC, CP, RA
LEVEL: ●
FORMAT: SESSION
Room 121c
Good Clinical Practice (GCP) through Good
Documentation Practices (GDPs)
Room 118c
Pharmacy
CHAIRPERSON
Emerging Role of the Patient Voice on Drug Policy
in Japan
Paul Swidersky
President, Quality Associates, Inc.
CHAIRPERSON
The requirements for providing credibility to clinical study data require that
each site assure full reconstructibility of the data that is generated by each
of its personnel. Good Documentation Practices (GDPs) require attributes
of data that will be defined and explained. They include not only recording
the data directly and promptly, but assuring legibility, attributability, and
durability. The reconstructibility of records will be shown to include linking
study-specific data to site-specific records, such as which equipment was
used for each subject, temperature logs, calibration records, qualification
and training records, and addressing data recording issues in the subject's
diary. Proper correction techniques will be described for manual data entries.
Examples will illustrate gaps that auditors routinely identify in clinical data.
Professor, Regulatory Sciences, Faculty of Pharmacy, Keio University, Japan
Patients and lay people in Japan now form one of the major groups that
support current drug development, safety, supply, and regulatory affairs.
This session will discuss recent change and the significant effect of the
patient voice on drug policy and the progress of the amendment of the
Pharmaceutical Affairs Law.
Hiromi Matsumoto, Esq.
Patient Advocate, Nattokushite Iryou Wo Ukerukai (Patient Understand
Medical Care With Own Decision), Japan
Keiko Ebihara, DrPH
Director, Regulatory and Vaccine Policy Group, Health Policy and
Access, MSD K.K., Japan
Quality Assurance Expert, Clinical and Pre-clinical Studies
Molly Butler
Consultant, Quality Associates, Inc.
Chief Safety Officer, Pharmaceuticals and Medical Devices Agency
(PMDA), Japan
#388 TRACK 13A – HEALTH ECONOMICS AND OUTCOMES
#386 TRACK 10B – PUBLIC POLICY/HEALTH CARE
3:30 PM–5:00 PM
Room 113c
LEVEL: ■
CME and Nursing
FORMAT: FORUM
3:30 PM–5:00 PM
FORMAT: FORUM
LEVEL: ■
Room 107ab
The Role of Meta-analyses in Drug Safety:
Methodological Considerations
Regulatory Capacity Building from 360 Degrees
CHAIRPERSON
Ekopimo O. Ibia, MD, MPH, FRCP
Director and US Regulatory Policy Lead, Global Regulatory Strategy, Policy,
and Safety, Merck & Co., Inc.
CHAIRPERSON
Simone P. Pinheiro, DrSc, MSc
Epidemiologist, Team Lead, Office of Surveillance and Epidemiology,
CDER, FDA
Regulatory capacity building is a critical activity to ensure the global access
and supply of safe and effective pharmaceuticals. Health authorities, nonprofit entities, and international organizations priorities and activities will
be presented.
Although the value of meta-analyses in drug efficacy is established, their
role in evaluating harm needs consideration. The role of meta-analyses and
the reporting of methodological considerations in published meta-analyses
will be discussed. The panel will also focus on additional questions such
as when are these studies most useful to inform clinical and/or regulatory
decision making, and what are the critical elements that should be included
FDA’s Point of View on Global Regulatory Capacity Building
Katherine C. Bond, PhD
Supervisory Management Analyst, Office of International Activities and
Strategic Initiatives, Office of the Commissioner, FDA
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Wednesday, June 27
in a framework to assess reporting of methodological considerations of
meta-analyses in drug safety?
The OMERACT 3x3 Table: A First Step to Assess Harm and Benefit in
Clinical Trials in One Scale
Maarten Boers
Professor of Clinical Epidemiology, Department of Epidemiology and
Biostatistics, University of Amsterdam, Netherlands
Secondary Use of Randomized Controlled Trials to Evaluate Drug
Safety
Tarek A. Hammad, MD, PhD, MS
Deputy Division Director, Division of Epidemiology-I, CDER, FDA
PHARMACOVIGILANCE
Design and Analysis Reporting in Meta-analyses of Randomized
Controlled Trials with Focus on Drug Safety
Simone P. Pinheiro, DrSc, MSc
Epidemiologist, Team Lead, Office of Surveillance and Epidemiology,
CDER, FDA
3:30 PM–5:00 PM
Room 115c
Doping Abuse of Medicines in Sport: The Challenge
to Industry and Regulators
Panelists
C. George Rochester, PhD, MA, RN, RAC
Associate Director for Safety Assessment, Office of Biostatistics, Office
of Translational Sciences, CDER, FDA
CHAIRPERSON
Barbara Leishman, MA
Head, Quality Risk Management – Safety Science, F. Hoffmann-La Roche
Ltd., Switzerland
Soledad Cepeda
Director, Epidemiology, Johnson & Johnson
Ahead of the 2012 Olympics, this session will highlight the many and varied
ways in which medicines are misused for performance enhancement and
address opportunities for companies to work proactively with World AntiDoping Agency (WADA) to mitigate the risk of abuse.
#389 TRACK 13B – HEALTH ECONOMICS AND OUTCOMES
3:30 PM–5:00 PM
Related Interest Area(s): CR, RD, PPLCC
FORMAT: SESSION
LEVEL: ■
Why Should We Collaborate with the World Anti-Doping
Agency (WADA)?
Olivier Rabin, PhD
Science Director, World Anti-Doping Agency (WADA), Canada
LEVEL: ■
FORMAT: SESSION
Room 116
Benefit Versus Risk of Harm: Assessing Therapeutic
Response and Interpreting Benefit/Risk with
Patients
Early Cooperation with World Anti-Doping Agency (WADA) within R&D
Mark A. Luttmann
World Anti-Doping Agency Cooperation Coordinator, Glaxosmithkline
CHAIRPERSON
The Scourge of Doping with Our Medicines: What Should We Do?
Steven Elliott, PhD
Scientific Executive Director (retired), Amgen Inc.
Lee S. Simon, MD
Consultant, SDG LLC
This session will highlight the importance of interpretation of the benefits
versus the risks of harm when assessing responsiveness to a therapeutic agent and how different stakeholder groups interpret these results.
Discussions will include calculations of number needed to treat for benefit
and number needed to treat for placing patients at risk of harm. They will
also address how patient-reported outcomes may impact these data and
what this can tell stakeholders about the usefulness of a therapy.
THINKING
3:30 PM–5:00 PM
Related Interest Area(s): CEHTAEbM
LEVEL: ■
FORMAT: SESSION
Room 113a
Statistical Comparative Effectiveness Research
(CER): Closing the Gaps in the Consideration of
Observational Evidence
This session is hosted by Outcome Measures in Rheumatoid Arthritis Clinical
Trials (OMERACT).
OMERACT: An International Effort to Develop Data Driven Consensus
Regarding Outcomes in Rheumatic Disease Studies — Collaborating
with Patients in Determining the Important Outcomes for Efficacy
and Safety
Lee S. Simon, MD
Consultant, SDG LLC
CHAIRPERSON
Joan K. Buenconsejo, PhD, MPH
Statistics Team Lead, Division of Biometrics II, Office of Biostatistics, Office of
As health care costs continue to rise and as new diagnostic and treatment alternatives become available, it is natural to ask which approaches
work best. Comparative effectiveness research (CER) or patient-centered
outcomes research aims to address this. Ideally, randomized trials could
be conducted to formally test superiority or non-inferiority of alternative
treatments. However, such trials are not always feasible or ethical, can be
very large, of long duration, and costly, and it is not clear whose responsibility it should be to fund and conduct the trials. Many of these trials do not
reflect real-world conditions of product use for either patients or health
care providers. Interested groups are more often turning to observational data to address relative effectiveness questions. Unlike the primary
analysis of a well-designed randomized trial, the operating characteristics of even a similarly well-designed observational study are not known.
Randomized pragmatic trials with limited exclusion criteria, no blinding and
Patient-centered Research: The OMERACT Model, How and Why It
Works
Amye Leong, MBA
President & CEO, Healthy Motivation, Patient Research Partner, OMERACT
Credible, Useful Patient Decision Aids: The Power of the OMERACT
Model for Patient Collaboraton in Design and Development
Thasia G. Woodworth, MD
Visiting Clinical Researcher, Geffen School of Medicine, UCLA,
OMERACT, Canada
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Wednesday, June 27
observational follow-up can be an alternative but are still subject to biases.
This session focuses on ways to quantify and improve the reliability and
validity of observational evidence generated by CER.
3:30 PM–5:00 PM
Related Interest Area(s): SUBS, RA, IT
FORMAT: SESSION
CME and Nursing
LEVEL: ●
FDA Perspective
LaRee A. Tracy, PhD, MA
Statistical Team Leader, Office of Biostatistics, CDER, FDA
Room 121ab
The State of Electronic Submissions at CDER,
CBER, and CDRH
The Challenges of Multiplicity from Subgroups and Multiple
Outcomes in Comparative Observational Research
Cynthia J. Girman, DrPH
Senior Director, Epidemiology, Merck Research Laboratories
CHAIRPERSON
Deputy Director, Office of Business Informatics, CDER, FDA
CDER, CBER, and CDRH are working towards all-electronic environments,
in order to streamline and facilitate the review of electronic submissions.
This session focuses on Center goals, experiences and practical advice for
sponsors and consultants.
Evaluating the Impact of Unmeasured Confounding in Comparative
Observational Research
Douglas E. Faries, PhD
Senior Research Advisor, Eli Lilly and Company
CDRH Update
Terrie Reed, MLS, MS
Associate Director, Informatics, CDRH, FDA
#392 TRACK 16A – PROFESSIONAL DEVELOPMENT
3:30 PM–5:00 PM
CBER Update
Michael Blanchard Fauntleroy
Program Manager, CBER, FDA
Related Interest Area(s): CR, PM, PETD
LEVEL: ●
FORMAT: SYMPOSIUM
Room 117
Learning Through Knowledge Sharing and Virtual
Worlds
CDER Update
Virginia Hussong
Team Leader, Electronic Submission Support, Office of Business
Informatics, CDER, FDA
CHAIRPERSON
Donna Ellender, PhD
Regulatory Sciences, Sanofi, France
Panelist
Hilmar Hamann, PhD
Director, Office of Business Informatics, CDER, FDA
This symposium will address how knowledge management and collaboration can lead to and aid in innovation — setting up, and building on,
knowledge management systems, using ideas from academia and the
pharmaceutical industry.
Best Practices for Virtual 3D Learning and Collaboration
Glenn Wise
Associate Director, PPD
3:30 PM–5:00 PM
LEVEL: ■
FORMAT: FORUM
Room 119a
India Town Hall
Fostering Research and Scholarship Through Knowledge Sharing
Jay Liebowitz, DrSc
Orkand Endowed Chair in Management and Technology, University of
Maryland University College
CHAIRPERSON
Kaushik Desai
Director, DIA India, DIA (India) Private Limited, India
Industry Perspectives on Transforming Pharmaceutical Companies
into Knowledge Organizations
Marcus Droege, PhD, MBA
Director, Global Medical Affairs, Takeda Pharmaceuticals
International, Inc.
Representatives from the regulatory authority of India will provide updates
on initiatives, guidances and regulations in their country, and the audience
will have an opportunity to address the esteemed panel.
Deputy Drugs Controller, Central Drugs Standard Control Organization,
India
#393 TRACK 16B – PROFESSIONAL DEVELOPMENT
3:30 PM–5:00 PM
LEVEL: ●
Related Interest Area(s): ALL
FORMAT: WORKSHOP
Room 123
DIA 2013: Helpful Hints in Submitting an Abstract
3:30 PM–5:00 PM
Related Interest Area(s): CR, RD
FORMAT: SESSION
CME and Nursing
LEVEL: ●
Room 115a
Rare Disease Clinical Research Consortia:
Immediate and Rich Sources of Translational
Research Data, Partnering Opportunities
CHAIRPERSON
Julie Ho
Manager, Annual Meeting Content Development, DIA
Join members of the DIA 2013 Program Committee and the DIA Annual
Meeting Team for tips and helpful hints as you submit a proposal for next
year's Annual Meeting.
CHAIRPERSON
Cindy Luxhoj Hahn
President and CEO, Alagille Syndrome Alliance
the Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they
Rare disease clinical research consortia offer a rich data source for
translational research. Investigating diseases from porphyria to pediatric
cholestasis, they present an array of collaborative opportunities for the
pharmaceutical industry.
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Wednesday, June 27
The Rare Diseases Clinical Research Network (RDCRN)
Rashmi Gopal-Srivastava, PhD, MSc
Director, Extramural Research Program, Office of Rare Diseases
Research, National Institutes of Health
3:30 PM–5:00 PM
CHAIRPERSONS
Martin Lee, MD
Executive Vice President, Clinical Trial Services, DAVA Oncology, LP
Slower than anticipated enrollment in cancer clinical trials is a common
problem. In this white paper showcase, we will describe the unique
challenges in cancer trials and efforts that have been made to increase
enrollment. Recommendations for best practice and areas for further
research will be highlighted.
The Patient Group Role in Rare Disease Research Consortia
Cindy Luxhoj Hahn
President and CEO, Alagille Syndrome Alliance
Room 122b
FORMAT: SESSION
Room 125
Accelerating Cancer Clinical Trials
The Childhood Liver Disease Research and Education Network
(ChiLDREN)
Ronald J. Sokol, MD
Chief, Section of Pediatric Gastroenterology, Hepatology and Nutrition,
Children’s Hospital Colorado
3:30 PM–5:00 PM
LEVEL: ●
Brought to you by DAVA Oncology, LP.
Related Interest Area(s): CR, PM, RA, PPLCC, QC
LEVEL: ■
FORMAT: FORUM
CME and Nursing
hosting this offering. If you prefer not to have your badge scanned, please inform the DIA staff
member.
Implementation of the Physician Payment Sunshine
Act: Now What?
Panelist
Mark Levonyak
President, DAVA Oncology, LP, United States
CHAIRPERSON
John F. Kamp, JD, PhD
Executive Director, Coalition for Healthcare Communication
This controversial provision of the Affordable Care Act has its proponents
and its critics, but, as it goes into effect, this panel will focus on its likely
impact on the public health and all the stakeholders — government, lawyers and accountants, the pharmaceutical and medical device industries,
researchers and investigators, physicians, and others. The panelists, representing a cross-section of interest areas, will take a look at the burdens and
benefits, the potential impact on clinical research, the advantages offered
by the resultant transparency and how all of this will play out with the
public and organized medicine.
5:00 PM
END OF WEDNESDAY
OFFERINGS
5:15 PM–7:30 PM
Room 117
Consortium of Academic Programs in Clinical
Research
John J. Lewis, MA
Vice President, Public Affairs, Association of Clinical Research
Organizations (ACRO)
Thomas P. Stossel, MD
Director, Translational Medicine Unit and Center for Medical Innovation,
Brigham & Women’s Hospital
Sandra J. P. Dennis, JD
Deputy General Counsel, Biotechnology Industry Organization (BIO)
Daniel Carlat, MD
Director, Pew Prescription Project
Marjorie E. Powell, JD
Senior Assistant General Counsel, PhRMA
105
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108
Thursday, June 28
Portfolio Management Theory Overview
Research, Inc.
THURSDAY, JUNE 28
Registration Hours:
8:00 AM–11:00 AM
Broad Street Lobby
Development of a Framework for Benefit-risk Considerations in
FDA/CDER
Patrick Frey
Director, Office of Planning and Analysis, CDER, FDA
Schedule:
8:15 AM–9:00 AM
Meeting Room 108 and 119 Concourse
9:00 AM–10:30 AM
10:30 AM–10:45 AM
Coffee Break
Meeting Room 108 and 119 Concourse
10:45 AM–12:15 PM
12:30 PM–5:00 PM
Room 108A
Commercial Valuation Considerations in Portfolio Management
Keith Ruark, MBA
Vice President, Avos Consulting
9:00 AM–10:30 AM
#401 TRACK 01 – CLINICAL OPERATIONS
9:00 AM–10:30 AM
Room 111ab
Related Interest Area(s): CR, FI, CDM
LEVEL: ■
FORMAT: SYMPOSIUM
CHAIRPERSON
Raul Soikes, MA
Senior Director, Program Management R&D, Baxter HealthCare Corporation
CHAIRPERSON
Parties need to recognize that alignment in objectives and complementary
expertise are needed to nurture a partnership and move from a transactional relationship to a skill and resource integrated commercialization
strategy. In this session, we will explore the degree to which a partnership
was mutually beneficial to each of the involved parties, the novelty of the
business model and strategic relationship, and the long-term future and
development of the partnership.
Keith W. Wenzel
Senior Director, Perceptive Informatics
This symposium will present and discuss the key metrics that should be
considered by sponsors to effectively monitor and manage the operational,
financial and clinical progress of their clinical drug/device trials.
The Vital Role of Patient-reported Data for Monitoring Study
Compliance and Overall Performance
Keith W. Wenzel
Client Perspective
Kimberly S. Hartman, MS
Director/Team Lead, External Supply, Pfizer Inc
Metrics and Benchmarks: Using Data to Improve Clinical Operations
Otis Johnson, MPA
Manager, Global Trial Optimization (GTO), Clinical Research Operations,
Merck & Co., Inc.
Supplier Perspective
Matthew Crowley
Global Account Manager, BD Medical Pharmaceutical Systems
Developing a Trusted Partnership
Colleen K. Dixon, MS, PMP
Site Director, Project Management, MedImmune
Integrating Site Metrics into the Site Selection, Planning, and
Contracting Process to Improve Performance and Reduce Risk
Melissa Bolanos Hutchens
Consultant, KMR Group, Inc.
STRATEGIC PLANNING
Room 105ab
LEVEL: ◆
PMI PDUs
FORMAT: FORUM
Integrated Partnership: A Vaccine Case Study
Room 113c
Clinical Trial Metrics Symposium
9:00 AM–10:30 AM
LEVEL: ■
PMI PDUs
9:00 AM–10:30 AM
Related Interest Area(s): PM, CP, CDM
FORMAT: SESSION
LEVEL: ■
FORMAT: SYMPOSIUM
Room 109ab
Multistakeholder Development Partnerships:
Harnessing Differing Perspectives, Objectives, and
Strengths for Success
Managing Drug Development Portfolios in a
Safety-heightened Environment
CHAIRPERSON
CHAIRPERSON
Karen E. Jaffe, MBA, MS
Regulatory Research, Alfred Mann Biomedical Engineering Institute
Research, Inc.
The symposium will use case studies to detail operational lessons with
integration of multiple stakeholders in medical development processes.
Innovation centers bridge gaps between biomedical invention and creation
of successful products that improve lives.
Portfolio management is changing to place more emphasis on the risk/
benefit ratio. Since most new molecular entities can treat more than one
disease, companies may select for initial development diseases which have
a greater tolerance for potential risks.
109
Thursday, June 28
A Medical Science Liaison’s value proposition is that they are in the field
working with health care practitioners and they may be able to assist with
their home office colleagues’ needs. This session will explore those areas
where successful collaborations have occurred.
Harnessing the Power of Innovation in Academia
Karen E. Jaffe, MBA, MS
Regulatory Research, Alfred Mann Biomedical Engineering Institute
Collaboration with IMPAACT for a Pediatric Registration Program:
An Example of a Partnering Model between Pharma and Academia
Xia Xu, PhD
Senior Biometrician, Merck Research Laboratories
Medical Science Liaisons: Home Office Collaborations
Suzana Giffin
Executive Director, Medical Information, Scientific Affairs, Amgen Inc.
The Medical Science Liaison: An Integral Part of the Clinical Study
Team
Jannell Ribera DePalantino, PharmD, RPh
Associate Director, Medical Affairs Strategic Trials Team, Janssen
Services, LLC
Multistakeholder Product Development Partnerships to Accelerate
Development for Neglected and Underserved Indications
Karl D. Whitney, PhD
Director, Product Development, Rho, Inc.
9:00 AM–10:30 AM
Room 124
CLINICAL RESEARCH
Related Interest Area(s): BT, RA, NC
LEVEL: ■
FORMAT: SYMPOSIUM
CME and Nursing
9:00 AM–10:30 AM
Room 121c
Hot Topics Symposium
CHAIRPERSON
CHAIRPERSON
Cecil J. Nick, MS
FTOPRA, Vice President (Technical), PAREXEL Consulting, UK
Arik Gorban
Associate Vice President, Compliance and Quality, iGATE Patni Life Sciences
This symposium will highlight topics of relevance in the nonclinical and
early phase arenas. The first presentation will discuss current perspectives
on drug-transporter interactions in drug development and how results are
applied to add value to clinical development. The second presentation will
address efforts made to map and benchmark the process flow from nonclinical to early development. The third presentation will focus on the need
for early consideration of pediatric investigation plans (PIPs) to support
an indication in pediatric population, leading to an increased focus on the
relevance of nonclinical studies in juvenile animals.
Traditional validation, qualification, and risk management practices are not
feasible in cloud-based systems, and expectations for certain documentation cannot be met. This workshop will discuss how to manage compliance
in a cloud-based environment.
Drug-Transporter Interactions: Regulatory Perspectives and Clinical
Relevance
Richard Ridgewell
Associate Director, Drug Metabolism, Covance, Inc.
CLINICAL RESEARCH
Mapping the Nonclinical to Early Clinical Drug Development Arena
Stella Stergiopoulos
Project Manager, Tufts Center for the Study of Drug Development
9:00 AM–10:30 AM
Related Interest Area(s): EC, IT, SE
FORMAT: SESSION
LEVEL: ■
CME and Nursing
Room 107ab
The Cross-over Between Direct-to-patient Studies,
Social Media, and EDC
Juvenile Animal Studies and Pediatric Drug Development:
Experience from 5 Years of Pediatric Investigation Plans, after
European Pediatric Regulation
Dinah Duarte, PharmD, MSc
Head, Scientific Evaluation Unit, Directorate of Medicinal Products,
INFARMED, Portugal
CHAIRPERSON
Douglas Bain
Founder and CEO, eClinicalHealth Limited, UK
The traditional boundaries between ePRO, Electronic Data Capture (EDC)
and community health information sharing are blurring as community
principles of social media and direct-to-patient studies emerge. This session
examines how Patient Data Capture (PDC) has evolved in recent years, and
how this will impact the evolution of data acquisition in clinical trials.
COMMUNICATIONS
9:00 AM–10:30 AM
Related Interest Area(s): IT, VA, CP
FORMAT: WORKSHOP
LEVEL: ■
Related Interest Area(s): MC, CR, CP
FORMAT: SESSION
How Much Are ePROs Better than Paper PROs?
Valdo Arnera, MD
General Manager Europe, PHT Corporation, Switzerland
LEVEL: ■
Room 108b
Study Recruitment Challenges, Tailored Medical
Information Requests – OH MY! Have You
Maximized All Your Options
EDC's Evolution to PDC: Patient Data Capture
Douglas Bain
Founder and CEO, eClinicalHealth Limited, UK
CHAIRPERSON
Patient Perspective
Ben Heywood, MBA
President and Co-founder, PatientsLikeMe Inc.
David L. Cram, PharmD
Vice President, Medical Affairs RSS Team, Allergan, Inc.
110
Thursday, June 28
9:00 AM–10:30 AM
THINKING
9:00 AM–10:30 AM
Related Interest Area(s): GCP, CR, RA
LEVEL: ■
FORMAT: SYMPOSIUM
Related Interest Area(s): CDM, IT
FORMAT: SESSION
Room 113a
Open Source Statistical Software in Drug
Development: Challenges and Opportunities
Room 121ab
The Role of Corrective and Preventive Action
(CAPA) in GCP/GLP Audit Quality Management
Systems
CHAIRPERSON
Jose C. Pinheiro, PhD
Senior Director, Quantitative Decision Strategies, Janssen Research &
Development, LLC
CHAIRPERSON
Michael R. Hamrell, PhD, RAC
President, MORIAH Consultants
Use of open source software in clinical drug development has been hampered by the incorrect perception that it cannot be validated and, therefore,
is not acceptable for regulatory submissions. This session will discuss the
challenges, perceived and real, to the broader utilization of open source
statistical software in drug development (in industry, as well as in NIHsponsored trials), and opportunities for addressing those challenges. It
will feature speakers with practical experience with the use of open source
software in drug development.
Corrective and Preventive Action (CAPA) have become an integral part of a
GCP Quality Management System approach. A formal program for CAPA is
becoming an integral means for meeting FDA and global regulatory expectations for clinical trial quality. The relationship between documentation,
deviations and corrective actions is becoming more clear with each 483
letter issued by the FDA. The ability to effectively manage your SOPs, track
training and associate them to CAPA resolution is vital.
FDA Perspective and Experience with Open Source Software
Mat Soukup, PhD
Team Lead, Office of Translational Sciences, Center for Drug Evaluation
and Research, FDA
Utilizing Monitoring Findings to Identify Events Requiring a CAPA
Deviation Management: SOPs and CAPAs for GCP, GLP and GMP
Warren Perry
Compliance Consultant, QUMAS
Developing and Utilizing Open Source Software for Clinical Drug
Development in a Biopharma Industry Environment
Vladimir Dragalin, PhD
Senior Vice President, Clinical Trial Innovation Strategies, Aptiv Solutions
Automating GCP/GLP Audit Reporting Processes in a Quality
Management System
KR Karu
Industry Principal, Sparta Systems
The Qualification and Validation of Open Source Software
Seth Berry, PhD
Director, Quintiles
PHARMACOVIGILANCE
9:00 AM–10:30 AM
LEVEL: ■
Related Interest Area(s): CDM, CP, DM
LEVEL: ■
FORMAT: WORKSHOP
CME and Nursing
9:00 AM–10:30 AM
Related Interest Area(s): MC, CmbP, PM
LEVEL: ●
FORMAT: SYMPOSIUM
Room 123
Coding with Confidence
Room 125
Left to Your Own Devices
CHAIRPERSON
CHAIRPERSON
Judy E. Harrison, MD
Senior Medical Officer, MedDRA MSSO
Matthew Pepe
Division Director, Workforce Integration
This workshop will provide an overview of coding safety data with
MedDRA®. Participants will apply the key principles in the "MedDRA® Term
Selection: Points to Consider” document by engaging in practical coding
exercises in an interactive format.
In today's market, professionals look to move between pharmaceuticals
and the medical device industry for the experience, to innovate, and frankly
out of necessity. In this symposium, through examples from the device
industry, you will discuss what it takes to transition from one industry to the
other, industry and academic collaborative educational programs, and to
recognize cultural imperatives to save face and devise project management
approaches to mitigate the organizational and business risks of this. All are
valuable and interesting on their own merit, and have applications to any
other regulated industry.
Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are
strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more
participants will be admitted. Interested attendees are encouraged to arrive at workshops early in
Practical Experience Applying Coding Principles and Conventions
Jean D. Cole, PharmD
Associate Director, Drug Safety and Public Health, Gilead Sciences, Inc.
Career Transitions Between Device and Pharma: Why the Stigma?
Matthew Pepe
Division Director, Workforce Integration
Saving Your Project from Your Team's Need to Save Face
Nermeen Y. Varawalla, MD, PhD, MBA
Founder & CEO, ECCRO, UK
111
Thursday, June 28
Strategic Development Planning: Designing Fast and Efficient
Programs
Research, Inc.
Innovative Learning Opportunities: A Collaboration between
Industry and Academics
William Gluck, PhD, MS
Vice President, DCCS, DATATRAK International
Evaluating Cost and Complexity of a GI Cancer Study Design Using
an FDA Software Tool
Philip Dehazya, PhD
Program Director, Oncology Business Unit, Aptiv Solutions
9:00 AM–10:30 AM
Room 114 AUD
FORMAT: FORUM
LEVEL: ●
CME and Nursing
Strategies for Controlling Study Costs
Michael Palmer, MS
President, Adaptive Pharmacogenomics, LLC
CHAIRPERSON
Nancy D. Smith, PhD
ORISE Fellow at FDA/Adjunct Professor, Temple University
Part 2 of this forum will take place on Thursday, June 28th at 10:45 AM.
The leadership team of CDER will be invited to participate in this forum. The
topics that will be discussed will depend on the audience and on areas that
are of current importance within the CDER community.
Submit your questions in advance to [email protected]
Subject: CDER Town Hall.
LEVEL: ■
Room 111ab
PMI PDUs
Related Interest Area(s): OS, CR
FORMAT: SESSION
Preferred Provider Relationships: Yesterday's
Obstacles, Today's Successes, and Tomorrow's
Vision
Panelists
CHAIRPERSON
Melinda K. Davis
Senior Director, Clinical Services, ClearTrial, LLC
This session will focus on the evolution of the preferred provider relationship. Representatives from pharmaceutical companies and CROs will share
how they make this relationship work, as well as their thoughts on how this
trend will continue to evolve.
John K. Jenkins, MD
Director, Office of New Drugs, CDER, FDA
Justina A. Molzon, JD, MPharm, CAPT. USPHS
Associate Center Director for International Programs, CDER, FDA
Sponsor-CRO Relationships: Insights into Current Practices, Industry
Challenges, and Future Opportunities
Patricia Leuchten
CEO and President, The Avoca Group Inc.
10:30 AM–10:45 AM
10:45 AM–12:15 PM
Strategic Alliances: Key Learnings and Emerging Models from the
CRO Perspective
Tim Dietlin, MBA
Vice President, Alliance Development, INC Research, Inc.
COFFEE BREAK
Meeting Rooms 108 And 119 Concourse
STRATEGIC PLANNING
10:45 AM–12:15 PM
LEVEL: ■
10:45 AM–12:15 PM
Related Interest Area(s): CR, PM, FI
FORMAT: SESSION
LEVEL: ■
PMI PDUs
Related Interest Area(s): OS, IT, CR
FORMAT: SESSION
Room 109ab
Using Technology to Build Successful Strategic
Outsourcing Partnerships
Room 105ab
Strategically Reduce Study Cost by Controlling
Study Design Cost Drivers, with Attention to
Studies with Biomarkers
CHAIRPERSON
Robert Nichols, MSc
Senior Director, Global CRO Partnerships, Oracle Health Sciences, UK
CHAIRPERSON
Utilizing technology has long been seen as a key tactic to drive efficiencies in the clinical development process. Strategic partnerships see
this value amplified as technology becomes an underlying part of the
pharma-CRO relationship.
Michael Palmer, MS
President, Adaptive Pharmacogenomics, LLC
Development planning, including modeling study cost, is critical to the
success of any product. A rigorous methodology based on research done
with the FDA and a large pharma exists for objectively and quantitatively
modeling and understanding study cost, including studies with biomarkers. Guided by this modeling, the clinical development strategist can revise
study strategy to save money while preserving objectives.
New Frontiers: Using Technology to Build Partnerships
Thomas C. Grundstrom, MA
Vice President, Integrated Process and Technology, Quintiles
Business Technology Approaches to Enable Successful Clinical Trial
Operations Partnerships
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Thursday, June 28
David Pasirstein, MS
Director Architecture, Global Clinical Development, MRL IT, Merck &
Co., Inc.
Mastering the Role of the Single Point of Contact: The Changing Role
of the US, EU-based Medical Writer
Thomas J. Purcell, MS
Principal and Owner, Urtech Medical Writing & Consultancy, LLC
Information: A Strong Foundation for Successful Partnerships
Raghu S. Chintala
Vice President, Project Management, ICON PLC
Who's Got Style? How to Create or Modify Company Style Guides for
the Best Results
Dawn Pirozzi Maxemow
Senior Medical Editor, INC Research, Inc.
10:45 AM–12:15 PM
Maximizing Time and Talent: Stakeholder Management in Medical
Writing Document Reviews
Lisa Pierchala, MPH
Manager, BioStatistics and Medical Writing, MMS Holdings Inc.
Related Interest Area(s): NC, CP, RD
LEVEL: ●
FORMAT: SESSION
CME and Nursing
Room 103b
Strategies for Implementing Dried Blood Spot
Drug Development and How the Technology
Supports the 3Rs Principles
CLINICAL RESEARCH
CHAIRPERSON
10:45 AM–12:15 PM
Fumin Li, PhD
Senior Staff Scientist, Covance, Inc.
Room 103a
Data Warehousing: Buzz Word or Panacea?
Dried blood spot (DBS) sampling is gaining momentum as an alternative to
plasma in support of drug discovery and development. DBS provides significant ethical benefits with reduced animal usage, using the 3Rs principle
(animal reduction, refinement, and replacement), and higher data quality in
safety assessment.
CHAIRPERSON
Dimitri Kutsenko, MA, MBA
Entimo AG, Germany
The data warehousing symposium will illuminate this current trend in the
pharmaceutical industry from entirely different perspectives. We will critically look at the topic and analyze the reasons which make data warehousing projects a failure or success. The symposium will offer a platform to
share experiences and shape ideas on future data warehousing developments in the pharmaceutical industry. We would like to invite all critical
and visionary people to join the symposium and to discuss this "new” data
warehousing trend.
Strategies for Use of DBS in Discovery through Early Clinical
Development
Patricia A. Zane, PhD
Associate Director, Sanofi
Adopting Dried Blood Spot Sampling to Support Drug Development
Enaksha Wickremsinhe, PhD
Principal Research Scientist, Drug Disposition, Eli Lilly and Company
The Virtual Biobank a Paradigm Shift
Andreas Wenger, MSc
Solution Manager, F. Hoffmann-La Roche AG, Switzerland
Moving Forward with Microsampling: DBS, Whole Blood, Plasma
John A. Dunn, PhD
Director, GlaxoSmithKline
The Network of Postmarketing: the Sixty-three Italian Drugs
Registries
Entela Xoxi, PharmD, PhD, MSc
Pharmacologist, Clinical Trial Office, Italian Medicines Agency (AIFA),
Italy
COMMUNICATIONS
10:45 AM–12:15 PM
Related Interest Area(s): CDM, VA, EC
FORMAT: SYMPOSIUM
CME and Nursing
LEVEL: ■
Related Interest Area(s): MW, OS, IT
LEVEL: ■
FORMAT: SYMPOSIUM
How to Leverage Clinical Data Warehousing with Smart
Metadata Handling?
Dimitri Kutsenko, MA, MBA
Entimo AG, Germany
Room 108b
Medical Writing Competencies and Best Practices
in the Global Environment
CHAIRPERSON
Thomas J. Purcell, MS
Principal and Owner, Urtech Medical Writing & Consultancy, LLC
CLINICAL RESEARCH
Many companies outsource various tasks that could be performed by the
company itself. In the biopharmaceutical industry, one form of outsourcing
is known as functional outsourcing and one such function that has been
identified for functional outsourcing is medical writing. This symposium will
address ways in which to maximize the role of in-house writers with their
external counterparts and their internal customers, show the challenges
and benefits of implementing a company-wide style guide or rule book for
use by internal and external writers and editors, and present tried and true
strategies for developing strong document review teams and setting the
ground rules for team roles and responsibilities, particularly in instances in
which team members are geographically dispersed and represent a diverse
cross section of the organization.
10:45 AM–12:15 PM
Room 103c
LEVEL: ◆
PMI PDUs
Related Interest Area(s): EC, CDM, FI
FORMAT: SYMPOSIUM
Economic Considerations and Management in the
Modern Day Clinical Trial
CHAIRPERSON
Keith W. Wenzel
Efficient fiscal management of clinical trials has always been important,
but in today’s environment of decreased R&D spending, the pressures
for effective fiscal management of a drug or device trial have risen to an
all time high. This session brings together a biopharmaceutical company
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Thursday, June 28
representative and an eClinical vendor expert to discuss the economics and
fiscal management of today’s clinical trials.
Immunogenicity Risk Assessment for Therapeutic Peptides
Laura Salazar Fontana, PhD
Reviewer, Office of Pharmaceutical Science, Division of Therapeutic
Proteins, CDER, FDA
Get Serious about Reducing Costs: Deploying Technology that
Actually Has an ROI
CEO, Clinical Ink
Immunogenicity Assessment of Glatiramoids — Lessons Learned
Ety Klinger, PhD, MBA
Vice President, Research and Development, Proteologics, Ltd., Israel
The Holy Grail of CTMS: Paying Investigators on Clean Data
John E. Humphreys, MS
Product Director, CTMS, Perceptive Informatics
Immunogenicity of Therapeutic Peptides
S. Russ Lehrman, PhD
Principal, Lehrman Biopharma
Measurement with an EDC Yardstick: Engaging Your Study Team to
Create and Optimize Useful Metrics
Dan Miller
Senior Study Data Manager, Genentech, Inc.
THINKING
10:45 AM–12:15 PM
#421 TRACK 08 – REGULATORY AFFAIRS AND SUBMISSIONS
10:45 AM–12:15 PM
Room 107ab
LEVEL: ●
FORMAT: SESSION
Room 113a
Increasing Clinical Program Success with Modeling
and Simulation
Related Interest Area(s): RA, CDM, CR
LEVEL: ■
FORMAT: SESSION
CME and Nursing
Regulatory Handling of Ethnic Factors in Asian
Clinical Trial Data #3, Implication for Simultaneous
Global Development (SGD)
CHAIRPERSON
CHAIRPERSON
In this session, the presenters will share their experience and ideas on
how modeling and simulation can increase clinical program success
and enable program teams to make better decisions through the drug
development process.
Olga V. Marchenko, PhD, MS
Vice President, Innovation, Quintiles
Akio Uemura, PhD
Director and Head, Regulatory Affairs, Japan, Allergan Japan K.K., Japan
Countries in Asia are increasing requirements for clinical data generated in
their own region. In this session, we will outline expectations for handling
ethnic factors by both regulators and the industry, and discuss possible
future regulations.
Improving Clinical Study Design and Understanding Via Modeling
and Simulation
Jose C. Pinheiro, PhD
Senior Director, Quantitative Decision Strategies, Janssen Research &
Development, LLC
Asian Ethnic Similarities and Differences: PMDA Point of View
Yoshiaki Uyama, PhD
Director, Division of Regulatory Science Research, Office of Regulatory
Science, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Utilizing Modeling and Simulation to Optimize Phase 2 for Decision
Making
Brenda L. Gaydos, PhD
Research Fellow, Eli Lilly and Company
Asian Clinical Data Utilization for NDAs in Japan
Yoshihiko Ono, RPh
Director, Regulatory Policy and Intelligence, Pfizer Japan Inc., Japan
Improving Oncology Clinical Program by Use of Innovative Designs
and Comparing via Simulations
Donald A. Berry, PhD, FACP
Professor, Department of Biostatistics, M.D. Anderson Cancer Center,
The University of Texas
Experience in Utilizing Asian Clinical Data in Asian Drug
Development
Vice President, Regulatory Affairs, Asia Pacific, Allergan, Inc., China
PHARMACOVIGILANCE
10:45 AM–12:15 PM
10:45 AM–12:15 PM
Related Interest Area(s): NC, CR, RA
FORMAT: SESSION
LEVEL: ●
Related Interest Area(s): PETD, SP, MC
FORMAT: SYMPOSIUM
Room 113b
Building Rapport and Managing Communication
Filters for Breakthrough Collaborations
LEVEL: ◆
Room 113c
Immunogenicity of Therapeutic Peptides:
Regulatory Science Implications
CHAIRPERSON
Lynn King
Assistant Vice President, Clinical Operations, Rho, Inc.
CHAIRPERSON
Jill Conner, PhD, MS
Director, Teva Pharmaceuticals
Communication filters are those perceptions or outlooks that each of us
brings to every conversation we experience. Our filters have a profound
impact on the effectiveness of our communication. This session will help
participants recognize these communication filters and how to set them
aside during conversation to allow for successful collaborations.
Like proteins, synthetic peptide-based non-biologic complex drugs (NBCD)
are immunogenic and can be immunotoxic. This session will review causes
of immunotoxicity and suggests regulatory guidelines to ensure immunologic safety of new or follow-on peptide-based NBCD.
114
What's Getting Through? Building Rapport & Managing
Communication Filters for Breakthrough Collaborations
Lynn King
Assistant Vice President, Clinical Operations, Rho, Inc.
Whose Learning Is It Anyway? Evaluating Training Effectiveness
Kristina R. Barkhouser
Training Manager, Almac Diagnostics
Optimizing Hybrid Knowledge-sharing and Training when
Combining Media Events with Practical Experience-sharing Sessions
Brett Allen Thompson
Assistant Director, Regulatory Sciences, Global Regulatory Policy Sanofi
10:45 AM–12:15 PM
FORMAT: FORUM
LEVEL: ●
CME and Nursing
Room 114 AUD
CHAIRPERSON
Nancy D. Smith, PhD
ORISE Fellow at FDA/Adjunct Professor, Temple University
Part 1 of this forum will take place on Thursday, June 28th at 9:00 AM.
The leadership team of CDER will be invited to participate in this forum. The
topics that will be discussed will depend on the audience and on areas that
are of current importance within the CDER community.
Submit your questions in advance to [email protected]
Subject: CDER Town Hall.
Panelists
John K. Jenkins, MD
Director, Office of New Drugs, CDER, FDA
Justina A. Molzon, JD, MPharm, CAPT. USPHS
Associate Center Director for International Programs, CDER, FDA
12:15 PM
ANNUAL MEETING
ADJOURNED
12:30 PM–5:00 PM
Room 108A
115
Thursday, June 28
NOTES
116
PRECONFERENCE PROGRAM & TUTORIALS
Each Annual Meeting Preconference Program and Tutorial was led by a subject matter expert(s) who provided in-depth instruction on some of the today’s
hottest topics. DIA would like to take this opportunity to thank all of the preconference program speakers and tutorials instructors that were involved in the
Sunday, June 24 event.
TUTORIALS
TUT 20:
TUT 21
TUT 22
TUT 23
TUT 40
Japan Regulatory Environment: Overview of the Organization,
Processes, Systems, and Changes Affecting Pharmaceutical
Development
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services,
PAREXEL Consulting
Wendy Yan, PharmD
Global Regulatory Strategist, Bayer Healthcare Co. Ltd, China
TUT 41
FDA Enforcement: Understanding the Agency’s Authority,
How Violations Occur, How to Prevent Them, and How to
Respond If Violations Do Occur
Michael A. Swit, Esq., JD
Special Counsel, Duane Morris, LLP
Vice President, Operations, Metrics Champion Consortium
Global Market Access: Essential Knowledge for Clinical Trial
Design
John Brennick, MPA
Worldwide Market Access, Janssen Global Services, LLC
A Device Primer: 510(k)s, PMAs, IDEs
Barry S. Sall, RAC
TUT 25
Benefit and Harm: A Process to Express this Ratio Determined
by Consensus-driven Evidence
Lee S. Simon, MD
Consultant, SDG LLC
TUT 42
Regulatory Affairs for Biologics
Carol H. Danielson, MS, DrPH
President, Regulatory Advantage
TUT 43
Clinical Statistics for Nonstatisticians
Michael C. Mosier, PhD
Director, Biostatistics, EMB Statistical Solutions, LLC.
TUT 44
Early Phase Research: Navigating the 21st Century Landscape
for Phase 1 Trials
Nancy A. Lass, MD
President and Principal Consultant, NL Specialty Consulting, Inc.
Stacie J. Bell, PhD
Assistant Director, Clinical Pharmacology, Array BioPharma, Inc.
President, DWD & Associates
Maarten Boers, MD, PhD, Msc
Professor of Clinical Epidemiology, Department of Epidemiology
and Biostatistics, University of Amsterdam, Netherlands
TUT 30
Regulatory Affairs in the European Union: An Overview of
Registration Procedures for Medicinal Products in the EU
Brenton E. James, FTOPRA
Consultant, Strategic Regulatory Affairs in the European Union, UK
TUT 31
Leadership: How to Organize and Lead People in Group Work
Michael Laddin, MBA, MS
CEO, LeaderPoint
TUT 32
Designing, Operating, and Evaluating Patient Registries
President, Outcome
Howard E. Greenberg, MD, MS, MBA
Principal, HEG Associates
Barbara Isquith Arone, MS
Director of Professional Services, Outcome
TUT 33
TUT 34
Quality Oversight of CROs – Clinical Vendors
Liz Wool, BSN, RN, CCRA, CMT
President and Chief Executive Officer, QD-Quality and Training
Solutions Inc.
Jennifer J. Poulakos, PhD
Director, Clinical Quality Assurance, Astellas
Utilizing Chemistry, Manufacturing, and Controls in Drug
Development
Priya Jambhekar
President, PBS Regulatory Consulting Group Inc.
TUT 24
Understanding and Navigating the Regulatory System in China
Laurence Bin Huang, MS
Executive Director Regulatory Affairs & Branded Generics
Development, AstraZeneca Pharmaceutical Co., Ltd., China
Understanding Comparative Effectiveness Research (CER)/
Health Technology Assessment (HTA) in the Biopharmaceutical
Industry
Nancie E. Celini, MPH, DrPH
Chief Learning Consultant, CAB Inc.
TUT 45
Preparing for a US FDA Advisory Committee Meeting
Pete Taft
Founder and CEO, Taft and Partners/PharmApprove
TUT 46
Fundamentals of Project Management for Non-project
Managers
Joan Knutson, PMP
PM Guru Unlimited
TUT 47
Overview of Drug Development
George H. D’Addamio, PhD
President, PharmConsult, Inc.
TUT 48
Art of Writing a Clinical Overview
Patricia A. Matone, PhD
President, Scientific Information Services, LLC
PRECONFERENCE PROGRAMS
Vadim Tantsyura, MS, MA, DrPH
Director, Data Management, Infinity Pharmaceuticals
SAFE-BioPharma®: Trusted Identities for Cloud
Collaboration
Fourteen Steps from Research to Development
APCR: Win-win Strategies for the Sponsor-investigator
Relationship
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POSTER PROGRAM
Professionals and Students from all fields related to the mission of DIA will present their original research at this year’s DIA 2012 Annual Meeting. Posters will be
displayed in the Exhibit Hall, Level 2.
Monday, June 24, 11:00 AM–6:30 PM*
*Award Ceremony at 6:00PM
M 01
Effect Of Formulation pH On Micropore Closure In Microneedle
Enhanced Transdermal Drug Delivery
Priyanka Ghosh, MS
University of Kentucky
M 11
Bias Assessment in Progression-Free Survival Analysis Using
Interval-censored Methods
Chen Hu, MS
University of Michigan
M 02
Improvement of Obstetrics and Gynecology Patient Health by
Using Patient Safety Reporting System
Neha Dhananjay Nandedkar
Bharati Vidyapeeth’s College Of Pharmacy, India
M 12
Contract Research Organizations in China: Current and Future
Yunzhen Shi, MS
University of Macau, Macao
M 13
M 03
An Evaluation of the Gulf Cooperation Council (GCC)
Centralized Regulatory Review Process for Pharmaceutical
Products
Mohammed Hamdan Al Rubaie, MPharm
Cardiff University, Welsh College of Pharmacy, United Kingdom
The Death of New Racemic Drugs Was an Exaggeration
Enav Zipora Zusman
The Hebrew University of Jerusalem, Israel
M 14
Psychotropic Drug Use Among Autistic Individuals Enrolled In A
State Medicaid Fee-for-service Program
Krutika Jariwala, MS
University of Mississippi
Drug Adverse Events Surveillance with CDISC Standards for
Multiple Trials
Boram Wang
The Catholic University of Korea, Korea
M 15
Using Stochastic Control Methods and Pharmacokinetics to
Individualise Drug Therapy
Ben Francis, MSc
University of Liverpool, United Kingdom
Unmet Drug Information Needs and Clinical Adherence to
Immunosuppressant Drugs of Kidney Transplant Recipients
Minghui Li, MSc
University of Maryland
M 16
Seeking Predictable Subject Characteristics That Influence
Clinical Trial Discontinuation
Jai Shankar Kishore Babu Yadlapalli, MS
University of Arkansas for Medical Sciences
Pharmacovigilance and Drug Repurposing Model and
Application: A Case Study Using Electronic Health Record Data
Krystl Haerian, MD
Columbia University
M 17
Pursuing Orphan Designation in Japan: Benefits and Process
Monique Meigio
West Chester University
M 18
Influence of Clinical Research Investigator Fraud on Clinical
Trial Participation
Purnachandra Garimella, MS
University of Michigan
M 19
Recommendations for Improving e-Prescribing Technology
Design and Use in Pharmacies
Olufunmilola Odukoya, MS, RPh
University of Wisconsin System
M 20
A Probabilistic Sensitivity Analysis to Estimate the Impact of
Data Errors in a Randomized Trial to Eradicate H. pylori
Elisa L. Priest, MPH
University of North Texas
T 02
Which ePRO Modality is Appropriate for Your Study?
Jennifer Ross, MEd, MS
Almac Clinical Technologies
T 03
Situational Analysis of the Pharmacovigilance Activities in
Brazilian Public Industries: Collaborate to Innovate is Essential
Paulo Roberto Gomes dos Santos
Bio-Manguinhos | Fiocruz, Brazil
M 04
M 05
M 06
M 07
M 08
M 09
M 10
Evaluating Consumer Understanding of Prescription Label
Information: An Assessment of USP 2011 Recommendations
Megan Elizabeth Bensi
Ohio Northern University
Development and Application of a Universal Benefit-risk
Assessment Framework for Medicines
James Leong, MPharm
Health Sciences Authority, Singapore
Examination of the Adoption of FDA’s Bio-pharmaceutics
Classification System (BCS): A Qualitative Study
Namita Joshi, MSc
Influence of Patient and Hospital Level Characteristics on
Emergency Department (ED) Wait Time in US
Hemalkumar B. Mehta, MS
University of Houston
Tuesday, June 26, 11:00 AM–1:30 PM
T 01
Risk Evaluation and Mitigation Strategy (REMS): 18-Month
Assessment Report of Dalfampridine Extended Release 10 mg
Tablets
Calvin Mai
Acorda Therapeutics, Inc.
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Poster Program
T 04
The “Storyline Document”, A New Document Format for the
Use in Pre-submission Meetings
Sybille M. Eibert
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
T 17
Golimumab Risk Evaluation and Mitigation Strategy: Embarking
and Executing on the New Era in Drug Safety
Ralph DeHoratius, MD, FACP
Janssen Services, LLC
T 05
VVSymQ™: A Simple, Validated Measure of Varicose Vein (VV)
Symptoms That Can Be Administered Daily Using a Personal
Digital Assistant (PDA)
Ellen Evans
BTG International Inc.
T 18
Systematic MedDRA® Upgrade in Clinical and Post-marketing
Safety Databases
Susan Li, DrMed, PhD
Kai Research, Inc.
T 19
T 06
Modeling and Simulation in Early Drug Development
Nancy Wang, PhD
Celerion
Automated Semantic Web-mining for Analyzing Changes in
Trial Records Over Time and Identifying Rescue Countries
David J. Cocker
MDC Partners
T 07
Clinical Research and Development on Western Drug and
Traditional Chinese Medicine Interaction in Taiwan
Huang Yuan-Chao, PharmD
Committee on Chinese Medicine and Pharmacy, Taiwan
T 20
Managing Standards with Governance and a Data Warehouse
John Garrity
Millennium Pharmaceuticals, Inc.
T 21
T 08
CDISC ODM End-to-End: One Sponsor’s Approach
Stephane Auger
Danone Research, France
T 09
Safety Database Migration: Use of Standard E2B Files with
Automated Loading as an Alternative to Traditional Migration
Arvind Nagaraj
Deloitte Consulting, LLP
Corporate Integrity Agreements: Comparison of Technology
and Procedures and How They Have Changed Since Onset to
Most Recent
Tracy A. England, MBA
OpenQ
T 22
Survey of Pharmaceutical Industry Outcomes Liaison Practices
Efficiency and Cost Benefit Analysis of Narrative Automation
Using Six Sigma as Compared to Industry-wide Benchmarking
of Narrative Writing Using Traditional Methods and Resources
Grace Lee, MA
PA Consulting
T 23
Making the Point: Emphasis of Claims in Prescription and
Nonprescription Television Advertising
Adrienne Faerber, MS
University of Wisconsin
Clinical and Regulatory Considerations for the Development of
Therapeutic HIV Vaccines
Kelly Denice Whitley De Padilla, PharmD, RPh
PPD
T 24
The Effect of A-Bromo-4-Chlorocinnamaldehyde on Coxsackie
Virus B3-induced Myocarditis and the Mechanisms
Siwang Wang Sr, MS
Fourth Military Medical University, China
Building an Analytical Roadmap to Support the New Risk-Based
Site and Data Monitoring Strategy
DeAnn S. Hyder
Quintiles
T 25
R&D Knowledge Management Starts with Higher Quality Data
Robert O’Hara, MS
ResultWorks
T 26
Social Media and Pharmacovigilance: New Space for Signal
Detection & Socialvigilance
Maria Alejandra Vazquez-Gragg
RTI Health Solutions
T 27
Regulatory Labeling Experiences with the PSUR Worksharing
Process
Eileen S. Kahn, MS
Sanofi
T 28
Implementation Status of CTD, eCTD and Paper-free
Applications: A Global Overview
Rosanna Melchior, PharmD, MSc
Thomson Reuters
T 29
Autovaccine B7-H1IgV induced Antitumor Immunity and
Enhanced HER2 DNA Vaccine-derived Immune Responses
Yingqi Zhang, DrMed
W 02
Patient Preferences for Reminders in Clinical Trials: Improving
Both Compliance and Patient Experience
Graham Nicholls, MS
Almac Clinical Technologies, United Kingdom
T 10
T 11
T 12
T 13
T 14
T 15
T 16
Novel Approach to Literature Surveillance for Adverse
Events using OvidSP and EndNote Auto-import Function and
Customization
Neal J. Grabowski
Genzyme, A Sanofi Company
Capitalizing On US Public Use Files To Answer
Pharmacoeconomic Questions
Alex Exuzides, PhD
ICON
Ustekinumab Risk Evaluation and Mitigation Strategy:
Embarking and Executing on the New Era in Drug Safety
Jack McGowen
Infliximab Risk Evaluation and Mitigation Strategy: Embarking
and Executing on the New Era in Drug Safety
Brenda Sarokhan
Wednesday, June 27, 11:00 AM–1:30 PM
W 01
A Comparison of Adverse Event Coding of Ophthalmic Medical
Device Reports: MedDRA® and FDA Patient Problem Codes
Osas Ayela-Uwangue, MD, MPH
Alcon Laboratories, Inc.
119
Poster Program
W 03
Feasibility of Remote Medical Monitoring in Clinical Research
Utilizing Web-based Electronic Medical Record System
Joshua Zhang, MD
ARIAD Pharmaceuticals, Inc.
W 17
Implementation of a Pharma Company’s Publication Policy that
Ensures Compliance in an Increasingly Scrutinized Environment
Michelle Kissner, PharmD, RPh
Pfizer Inc
W 04
Virtual Technology Solutions: Gain Efficiencies and Increase
Control Over Global Sample Inventories During Clinical
Research
Lori Ball, MBA
Biostorage Technologies
W 18
Pharma Quality Agreements
Gloria Katherine Miller, RAC
Premier Research Group
W 19
Creating a Data-Driven and Quantitative Site Index Score for
Optimal Site Selection
Elizabeth Nielsen, MS
Quintiles, Inc.
W 20
Informatics - Linchpin or Afterthought of a Business
Externalization Strategy
Susan Butler, PMP
ResultWorks
W 21
Post-Doctoral Pharmaceutical Industry Fellowships:
Perceptions of Required Core Skills by Trainees and Preceptors/
Managers
Erica Hosek, PharmD, RPh
Rutgers, The State University of New Jersey
W 22
Statistical Evaluation of the Power of the Arc Sine Test against
the CMH Test for Stratified Data for Smaller Proportions
Hewa Saranadasa
Symbiance, Inc.
W 05
W 06
Application of Control Charting for Pharmacovigilance Signal
Detection
Neal J. Grabowski
Genzyme, A Sanofi Company
Preparation of Compassionate Use Data for Quality Regulatory
Submissions: Experience with Glucarpidase Development for
Methotrexate Toxicity
Claire Daugherty
W 07
The Impact of Patient Recruitment Methods on Data Quality
Patricia Brown, PhD
CNS Healthcare
W 08
The Gap Between Clinical Trials and Comparative Effectiveness:
A Case Study
Rachel L. Jao, MPH
Context Matters Inc.
W 23
W 09
The MURDOCK Community Registry and Biorepository:
Collaboration as the Driving Core of a Translational Research
Engine
Douglas Wixted, MS
Duke Translational Medicine Institute
Building Novel Clinical Research Capacity in Resource-Limited
Settings: Lessons Learned at Three Mozambique Sites
Kathleen Walker, PhD
U.S. Military HIV Research Program (MHRP)
W 24
Identification of Biomarkers in Gastric Cancer of Chinese Based
on SNPs Screening and its Evaluation in Clinical Application
Zhen Yan, MD, PhD
Preparing to Share CDISC SDTM Data: A Practical Evaluation of
Potential Error Sources and Effective Review Processes
Steve Kirby, JD, MS
Viropharma Incorporated
W 25
Study of Unique Feature of Regulatory Framework Under
Japanese Pharmaceutical Affairs Law in Japan
Michel Mikhail, PhD
Fresenius Kabi Deutschland GmbH, Germany
Current Drug Master File (DMF) Status in Taiwan
Fu-Chieh Lu, MSc
Center For Drug Evaluation, Taiwan
W 26
Validation of New Patient/Clinician Reported Outcome ToolCapturing the Visual Impact of Varicose Veins
Elizabeth Orfe
Producing Rules for Portugal to Improve Rational Prescribing
Pedro Caetano
Faculdade De Ciências Médicas, Universidade Nova De Lisboa
(nova Medical School), Portugal
W 27
To Develop a Process to Help Patients Adhere to a Prescribed
Haemophilia Therapy Regime
Christopher D. Watson, PhD
Exco InTouch, United Kingdom
W 10
W 11
W 12
W 13
Innovative Strategies to Enhance Minority Recruitment for
Clinical Trials
Lenore Threadgill Coleman, PharmD
Healing Our Village of Maryland, Inc.
W 14
Regulatory CMC BLA and NDA Submissions: Differences and
Correlations from Regulatory and Scientific Perspectives
David Donne, PhD
Janssen R&D, Johnson & Johnson
W 15
Medical Device Development Project Management: Is a
Paradigm Shift Needed?
Bernard Tyrrell
Mass College of Pharmacy & Health Sciences
W 16
Results of Patient and Physician Survey regarding Mobile Social
Media Adoption and Preferences
Jim Zuffoletti, MBA
OpenQ
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AWARD WINNERS
DIA Awards recognize significant individual or group accomplishments in the discovery, development or lifecycle management of pharmaceutical, devices, or
related products, and/or acknowledge significant volunteer contributions in the advancement of DIA’s mission and vision.
DISTINGUISHED CAREER AWARD
EXCELLENCE IN VOLUNTEER
LEADERSHIP AWARD
Daniel Brasseur, MD, PhP
PDCO Chairman
Federal Agency Medicines & Health Products
Belgium
The Distinguished Career Award recognizes and
honors an individual with a distinguished career in
the discovery, development, regulation, surveillance,
or marketing of pharmaceuticals or related products.
The recipient of this award has shown extraordinary
service and dedication to the advancement of healthcare through career contributions to pharmaceutical
and related industries that benefit industry, government and the patient.
Linda F. Bowen, MS, RAC, FRAPS
Senior Director, Regulatory Policy and Intelligence-US
Sanofi
United States
Deborah Dolan, MBA
Vice President, Key Accounts
AmerisourceBergen Corporation
United States
FOUNDERS’ SERVICE AWARD
Marie A. Dray
President
International Regulatory Affairs Group LLC
United States
Janet E. Davies, BPharm, MRPharmS, HonFPIPA
Director, International Medical Information
Gilead Sciences
United Kingdom
The Founders Service Award is named after the group
of 30 professionals who founded the DIA in 1964 with
a fundamental value that the Association is member
driven and fueled by the pharmaceutical industry’s
need for a neutral forum. This award is given with the
highest recognition and appreciation for volunteerism
in DIA. It recognizes those individuals who have
contributed to the advancement of the mission, vision
and values of the DIA and fostered its growth and
development through their dedicated and sustained
volunteerism.
This award is given to recognize the individual who has demonstrated
outstanding effective leadership during their dedicated and extensive
voluntary service to DIA. This individual has made consistent and significant
contributions to the Association, not only as a volunteer, but as a volunteerleader in various DIA roles. Some of these roles include leadership positions
in the following areas: meetings/workshops, communities, special committee
positions, advisory council, editorial board, author or DIA board membership.
The breadth and depth of their service as a leader to DIA should have a
lasting, positive effect in contributing to the fulfillment of the mission and
vision of the association.
JOURNAL AWARDS
THE THOMAS W. TEAL AWARD
FOR EXCELLENCE IN STATISTICS
PUBLISHING
Lee Kaiser, PhD
Director, Statistical Methods
and Research
Genentech Inc.
United States
This award recognizes the importance of articles on
statistics in the journal. It is named after Thomas W.
Teal, a DIA member since the mid-seventies, former
DIA executive director for 15 years, and editor-inchief of the Drug Information Journal for 18 years.
THE DONALD E. FRANCKE AWARD
FOR OVERALL EXCELLENCE IN
JOURNAL PUBLISHING
David Coutant, PhD
Principal Research Scientist
United States
This award is chosen by the Journal’s editorial
board and recognizes the most significant and
outstanding article published in the Journal in 2011.
121
STUDENT JOURNAL AWARD
Clive M. Mendonca,
BPharm, MS
Graduate Student, Department
of Pharmacy Administration and
Center for Pharmaceuticals
Marketing and Management,
School of Pharmacy
This award is selected by the DIJ editorial board
and presented to student contributors for articles
published in the 2011 Drug Information Journal.
Award Winners
OUTSTANDING SERVICE AWARD
The DIA Outstanding Service Award is given to recognize those individuals who consistently, through their volunteer efforts, have made contributions to DIA's
mission and vision over the past several years. These individuals have exceeded expectations in their volunteer activities with DIA.
Barbara J Godlew
Life Sciences Advisory Services
Huron Consulting Group
United States
Keiko Ebihara
Director, Regulatory and Vaccine Policy Group, Health
Policy and Access
MSD K.K.
Japan
Craig A. Metz, PhD
President
Metz Regulatory Consulting Services
United States
William Wang, PhD
Site Head, Department of Biostatistics and Research
Decision Sciences
Merck Research Labs
China
Marisa Papaluca, MD
Head of Scientific Support and Projects
European Medicines Agency, European Union
United Kingdom
Chuan Daniel Liu, PhD Director, China Development
Medidata Solutions, LLC
China
Nermeen Varawalla, MD, DPhil (Oxon), MBA
Founder & CEO
ECCRO
United Kingdom
Dr Arun D. Bhatt, MD, FICA (India), FICR (UK)
President
Clininvent Research Pvt. Ltd.
India
COMMUNITY AWARD
Eri Sekine
Head of Oncology, Biometrics and DM Department,
Oncology
Development
Novartis Pharma K.K.
Japan
Regulatory Affairs SIAC
The DIA Community Award is given to recognize a particular community
that has demonstrated its ability to be instrumental in fostering the
professional growth of their constituents while also advancing the mission,
vision and overall goals of DIA. This commitment to professional excellence
is shown through the variety of events and opportunities that the community has made available. The outcome of these activities increases a group
or individual’s professional development and global networking opportunities while working to achieve the DIA’s mission and vision.
Kyoichi Tadano, PhD
Director, Division of Planning and Coordination, Office
of International
Programs
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan
Award Accepted by Regulatory Affairs SIAC Chair:
Sarah Powell, RAC
Executive Director, Regulatory Affairs and Writing
Services
Liquent, Inc.
United States
122
SPEAKER INDEX
Speaker Name
Session No.
Abrams, Thomas W.
116, 332, 354, 413, 425
Adams, Andrew M.
237
Ahir, Sunita Prem
227, 361
Page No.
Speaker Name
38, 89, 94, 112, 115
66
64, 96
Session No.
Page No.
Berry, Donald A.
423
114
Berry, Seth
411
111
Bertino, Joseph S.
353
94
Binkowitz, Bruce
Program Committee, 234
Ahonkhai, Vincent I.
330
5, 88
Alcorn, Harry W.
130
42
Birks, Ian
Allard, Crystal
224
63
Bisio, Augustina
110, 166, 238
Anderson, Cathryn L.
345
92
Black, Lauren E.
107
36
352
12, 65
94
37, 51, 66
Anderson, Diana L.
264
73
Blackburn, Stella
143
46
Anderson, Margaret A.
208
5, 59
Blankstein, Larry
Program Committee
12
Ando, Tsuyoshi
304
82
Blumberg, Eric M.
316
85
Ando, Yuki
174
54
Boers, Maarten
389
103
Andrus, Jonathan R.
268
74
Bognar, Carol
363
96
Antonijevic, Zoran
201
57
Bond, Katherine C.
386
102
Archdeacon, Patrick
217
61
Boutin, Marc M.
312
84
Arnera, Valdo
408
110
Bowen, Linda F.
110, 277
Asahina, Yasuko
340
91
Brand, Scott
270
74
Astley, Nick
105
35
Brandenburg, Nancy A.
171
53
Auberson, Lillian
355
94
Breeden, John P.
239
66
Azevedo, Antoinette M.
273
75
Brennan, Michael J.
309, 374
Babani, Solomon
Program Committee
12
Brescia, Bonnie A.
327
Bachmann, Peter
148
54
Bretz, Frank
Bain, Douglas
408
110
Brodie, JoAnna R.
253
70
Bakare, Nyasha
119
39
Brodish, David
141
45
Baker, William
Ball, Leslie
325
114, 127, 280, 317
87
Bross, Kay
146, 234
36, 76
83, 99
87
46, 65
Program Committee
12
37, 41, 76, 85
Brown, Debby
241
67
Ball, Lori
381
101
Brown, Jackie
262
72
Bang, Soo Y.
372
98
Brown, Jeffrey
321
86
Program Committee
12
Brown, Paul
Program Committee
12
Barkhouser, Kristina R.
424
115
Brueckner, Andreas
344
92
Basmadjian, Kathleen
362
96
Buenconsejo, Joan K.
Bufferd, Gary M.
345
92
Bull, Jonca C.
359
95
Baranello, Roy
12, 103
Bass, Steven W.
277
76
Bates, Nicole
330
5, 88
Bauer, Martin
353
94
Bunch, Paul R.
202
57
Baughn, Anne-Marie
151
48
Burdette, Linda J.
250
70
Baylor-Henry, Minnie
Board of Directors
13
Burke, Laurie
153
48
Burkhart, Keith K.
221
62
Program Committee
12
Burmeister, Allison
125
41
314
84
Burt, Tal
353
94
Bayney, Richard
Beauregard, Annetta
Beck, Tracy J.
159, 206, 265, 379
50, 58, 73, 100
Belai, Ghiorghis
166
51
Bush, Laina
226
63
Benau, Danny A.
Student Forum
33
Busse, Gregory
158
49
Berger, Barry A.
316
85
Butler, Molly
387
102
Berlin, Conny
344
92
Butt, Rodney William
126
41
Berliner, Elise
255
71
Bye, Carol A.
254
70
Bernstein, Deena E.
101
34
Byrom, Bill
248
69
123
Speaker Index
Speaker Name
Session No.
Caffé, Steve
Board of Directors
13
Cooper, Charles K.
Caines, Patrick
320
86
Cooper, Karena
317
85
Callen, Laurie S.
270
74
Cote, Timothy R.
359
95
Campbell, Pamela
288
78
Cowall-Hanover, Patricia L.
209
59
Cantor, Michael N.
381
101
Coyle, Peggy L.
349
93
Cappuccino, Nicholas
237
66
Cram, David L.
406
110
Carita, Anthony J.
220
62
Crampton, Lindsay
256
71
Carlat, Daniel
397
5, 105
Program Committee
12
Carroll, Kevin J.
258
71
Casola, Thomas M.
354
Casselberry, Brooke
110, 277
Cavagnaro, Joy A.
331
Celini, Nancie E.
Cepeda, Soledad
388
Cerreta, Francesca
136, 340
Chamberlain, Richard L.
287
Chambers, Joan A.
125, 241
Page No.
Speaker Name
Cropp, Anne
Crowley, Matthew
94
Session No.
Page No.
123, 267
40, 73
403
Cruz, Celia N.
211, 364
37, 76
Cullity, Constance
229
88
Dal Pan, Gerald J.
116, 413, 425
12, 43
103
44, 91
78
41, 67
109
59, 97
64
38, 112, 115
Darling, Leslie
103
35
David, Jeannie C.
230
64
Davis, Chris
203
57
Davis, Melinda K.
415
112
Davis, Tim
216
61
Charles, Michelle
338
90
Day, Richard Osborne
Board of Directors
13
Charron, Jennifer
352
94
De Cuyper, Xavier
148
54
Chasse, Adam
242
67
de Faria Krim, Yasmin
271
74
Chen, Huiping
261
72
Dehazya, Philip
414
112
Chepesiuk, Ray
354
94
Deloa, Cari
357
95
Del Signore, Susanna
340
91
Chern, Herng-Der
304, 365
82, 97
Cherry, Tiffany Sizemore
281
77
De Nigro, Luca
Chew, Catherine Yu
158
49
Chew, Paul H.
Dennis, Sandra J. P.
397
5, 105
DePalantino, Jannell Ribera
406
110
360
96
De Rosa, Marisa
381
101
Childers, Karla
329
88
Desai, Kaushik
395
104
Chintala, Raghu S.
416
113
DeSanti, James
132, 207
Program Committee, 134, 384
7
49, 97
Chhatre, Dhananjay R.
Christl, Leah A.
EXEC Program
156, 365
13, 43, 102
43, 58
Deslypere, Jean-Paul M.F.
323
87
Cipollina, Joseph A.
338
90
Dhillon, Savita
274
75
Clark, Stephen J.
365
97
DiBiaso, Peter A.
203
57
Clarke, Cyril P.
107
36
DiCesare, Joseph
Clemons, Catherine Dabney
210
59
Dietlin, Tim
Clemow, David B.
205, 278
Cobert, Barton L.
231
305, 415
65
82, 112
58, 76
DiMasi, Joseph A.
362
96
213
60
Dixon, Colleen K.
403
109
Cogswell, Aron
104
35
Dolan, Kathleen T.
106
36
Cohen, Samuel M.
331
88
Dorozinsky, Donna W.
325
87
Cole, Jean D.
410
111
Dou, Jinhui
286
78
Coleman, Linda M.
256
71
Doyle, John J.
124, 231
40, 64
Collins, Suzanne
377
100
Dragalin, Vladimir
371, 411
98, 111
Coloma, Preciosa M.
257
71
Dray, Marie Allison
139
Conner, Jill
422
114
Connolley, Michael J.
302
81
Droege, Marcus
392
45, 54, 72
Drucker, Chuck
Program Committee
Cooke, Emer
142, 174, 260
Dreyer, Nancy
124
44
12, 45, 52
104
12
Speaker Index
Speaker Name
Session No.
Duarte, Dinah
405
Dubois, Robert W.
EXEC Program
Page No.
110
7
Speaker Name
Session No.
Page No.
Frey, Patrick
312, 402
84, 109
Fritsch, Kathleen S.
234
65
Dufeu, Carlos
333
89
Fritschel, Betsy P.
115
38
DuMouchel, William
322
86
Frueh, Felix
EXEC Program
7
Duncan, Ken
330
5, 88
Dunham, Corey B.
371
Dunn, John A.
Fuerst-Ladani, Shayesteh
361
96
98
Fung, Mann
375
99
417
113
Furuya, Yoshikata
163
50
Dustin, Joseph
268
74
Gagneten, Sara
163
51
Duvall, Beth
161
50
Ganley, Charles J.
111
37
Easom, Eric
122
40
Garrard, Elizabeth E.
Ebihara, Keiko
385
102
Garrett, Andrew
118
39
Eborall, Elain
318
85
Garrick, Owen
216
61
12, 65
Garrison, Skip
288
78
Edwards, Alan
150
40, 47
Gates, Cynthia M.
348
93
Eggleson, Kathleen K.
307
82
Gault, Jamie Lynn
337
90
Eibling, Andrew
129
42
Gawrylewski, Helle
247
69
39, 46, 53, 84, 101
Gaydos, Brenda L.
423
114
Edelstein Henry, Lauren
Eichler, Hans-Georg
120, 146, 172, 314, 383
Ellender, Donna
392
104
Gearhart, Natalie C.
Elliott, Steven
390
103
Geary, Stewart
Emmett, Andrew
161
50
Gensinger, Gary M.
Engelen, Sylvia
347
92
Gertel, Art
Epps, Carla L.
335
89
Getz, Kenneth A.
Erni, Fritz
12, 59, 97
Famulare, Joseph C.
318
85
Faries, Douglas E.
391
104
Getzen, Thomas E.
116, 144, 343
233
313, 360, 394
213, 222
EXEC Program, 219, 247, 374
38, 46, 91
12, 76
65
84, 96, 104
60, 62
7, 62, 69, 99
EXEC Program
7
Ghone, Ashok K.
326
87
Giangrande, Jennifer K.
240
67
Faulkes, John A.
128
42
Fauntleroy, Michael Blanchard
394
104
Giffin, Suzana
406
110
Feigal, David W.
164
51
Gintant, Gary
157
49
Felli, James
108
36
Girman, Cynthia J.
337, 391
Ferla, Jason
336
90
Gladson, Barbara
Program Committee
13
Ferrucci, Luigi
340
91
Gliklich, Richard
255
71
Glover, Paul
139
45
Findlen, Kathleen
Gibbs, Jeffrey N.
12, 60
113, 165
37, 51
90, 104
Finkle, John K.
315
85
Gluck, William
412
112
Fiore, Gregory J.
144
46
Glynn, Robert J.
143
46
Fisher, Harry J.
160
50
Godlew, Barbara
314
84
Goettner, Kristin Fox
205
58
Fitzmaurice, J. Michael
Flaherty, Kelleen
12, 74
Student Forum
33
Goller, Gretchen
152
48
Fleming, Alexander
357
95
Gombar, Charles T.
284
77
Flöther, Frank Ulrich
155
48, 49
Gommoll, Carl
310
83
Folino Gallo, Pietro
231
64
Goneconto, Gregg
324
87
Folkendt, Michael
230
64
Gonzalez, Carmen R.
373
99
Fookes, Kim
106
36
Gooen, Tara R.
254
70
Fotsch, Edward
170
52
Gopal-Srivastava, Rashmi
396
105
France, Georges L.
254
70
Gorban, Arik
407
110
Freunscht, Regina
140, 361
Governale, Laura
232
65
45, 96
125
Speaker Index
Speaker Name
Session No.
Gray, Mark A.
313
Page No.
Speaker Name
84
Ho, Julie
Session No.
393
104
Greberman, Melvyn
269
74
Hochberg, Alan M.
Green, Jody L.
366
97
Hoffman, Freddie Ann
286
78
Greenstreet, Yvonne
147
47
Hoffman, Michael D.
131
42
Greist, John
310
83
Holcroft, Stephen Paul
227
63
Grice, Kenneth
311
83
Holmlund, Jon
327
87
Griffin, Jane
263
73
Hong, Laura
137
44
Grinstead, Eric
370
98
Hoog, Truus Janse-de
Board of Directors
13
Grundstrom, Thomas C.
416
112
Horn, Marcia K.
312
84
Guerrero, Sergio
Page No.
163
12, 71
Board of Directors
13
Houn, Florence
Gupta, Sunil
347
92
Hoyle, Christopher J.
Gurachevsky, Andrey
103
35
Huang, James
Gwaltney, Chad
109
36
Hubbard, Frank C.
333
89
Haffner, Marlene E.
359
95
Hubby, Sherri A.
166
51
Hahn, Cindy Luxhoj
396
104, 105
Hudson, Kathy L.
208
5, 59
Hahn, Cynthia
217
61
Hulihan, Earl W.
287
78
Hahn, William R.
279
76
Hume, Samuel W.
311
83
140, 229
50
12, 34, 67
45, 64
Halim, Nader
319
85
Humphreys, John E.
420
114
Hamann, Hilmar
394
104
Hung, H.M. James
380
101
Hamburg, Margaret
139
45
Hussong, Virginia
394
104
Hammad, Tarek A.
169, 388
Hutchens, Melissa Bolanos
401
109
Hamrell, Michael R.
409
111
Hutchins, Richard S.
375
99
Hansen Bouchard, Rikki
377
100
Hynes, Martin D.
284
77
Hanson, Jeannine
278
76
Ibara, Michael A.
144
46
Haque, Zia
244
68
Ibia, Ekopimo O.
386
102
52, 103
Harbison, Christopher T.
303
81
Inglis, Anne Marie L.
352
94
Harley, Joan
240
67
Irizarry, Michael
145
46
Harpum, Peter
350
93
Irony, Telba
172
53
Harrison, Judy E.
Hartman, Kimberly S.
Harvey-Allchurch, Martin
Hasler, Steve R.
Hauber, Brett
356, 410
403
95, 111
Isidor, John M.
109
113, 165
Istas, Adam
124
40
75
Program Committee
13
Iwaoka, Teiki
275
135
43
Jackson, Ian
168, 318
53
172
37, 51
52, 85
Jacobs, Robert T.
122
40
Hayes, Clarice (Risa) P.
159, 223
50, 63
Jacobson-Kram, David
331
88
Heaslip, Richard J.
202, 284
57, 77
Jaffe, Karen E.
404
109, 110
Hecker, Sandra J.
131
Hegarty, Mark C.
113, 165
42
Jagota, Nirdosh
37, 51
34, 73, 78
Program Committee
12
Jamerson, Brenda
373
99
James, Sue E.
158
49
125
41
Helfgott, Jonathan S.
102, 263, 287
Hendrickson, Jean A.
351
93
Jay, Michael
Henry, Matthew C.
235
66
Jenkins, John K.
Hernandez, Adrienne
113
37
Jenkins-Showalter, Janet
161
50
Hess, Maureen
163
51
Jennings, Amy A.
379
100
Heywood, Ben
408
110
Jin, Shun
162
50
Hilke, Robert A.
328
88
Joergensen, Merete
276
76
Hinkle, Ellen
270
74
Johnson, James R.
214
60
126
413, 425
112, 115
Speaker Index
Speaker Name
Session No.
Johnson, Otis
401
109
Kuhnert, Betty R.
Johnson Rojas, Luis Eduardo
238
66
Kulkarni, Darshan
210
Jolley, Steve
275
75
Kurokawa, Tatsuo
233, 385
Jones, Allen
135
43
Kush, Rebecca D.
263
73
40, 82
Kutsenko, Dimitri
419
113
43
Kweder, Sandra L.
Board of Directors, 226
13, 34
Ladds, Graeme A.
343
91
Jordan, Patrick
124, 305
Joseph, John M.
135
Juillet, Yves
Board of Directors, Plenary
Page No.
Speaker Name
Session No.
235
Page No.
66
59
13, 65, 102
13, 63
Jung, Connie T.
324
87
Lamberti, Mary Jo
103
34, 35
Kafer, Jonathan
226
63
Lanfear, Mark
150
40
Kaitin, Kenneth I.
EXEC Program
7
Lappin, Graham
353
94
120
39
Larrabee, Kelly
373
99
Kalis, Aginus A. W.
Kamen, Dean
Plenary
4, 34
Kamp, John F.
397
5, 105
Kane, Robert
347
Kanjirathinkal, Becki
Lassoff, Peter M.
111, 227
37, 63
Lauf, Ian C.
220
62
92
LaVange, Lisa M.
118
38
228
64
Leahey, Mark B.
138
44
Karu, KR
409
111
Lee, Andy
129
42
Kasher, Jeffrey S.
127
41
Lee, Catherine
218
61
Katz, Nancy R.
278
76
Lee, Herbert B.
342
91
Kauffman, John F.
115
38
Lee, Martin
398
105
Keegan, Margaret M.
357
95
Lee, Young Jack
155
49
Kennedy, Cassandra
253
70
Leeder, J. Steven
221
62
Keshava, Ajay
320
86
Lehrer, Steven
252
70
Keskinaslan, Abdulkadir
212
60
Lehrman, S. Russ
422
114
Khan, Mansoor
121
39
Leishman, Barbara
127, 390
Kiernan, Matthew J.
302
81
Lenihan, Daniel J.
315
Kiester, Marci C.
313
84
Leong, Amye
Kim, Ock-Joo
166
51
Leuchten, Patricia
Kimber, Martin
248
69
Levins, Ilyssa
285
78
King, Lynn
424
114, 115
Levitan, Bennett
172
53
Kinnersley, Nelson M.
367
97
Levonyak, Mark
398
105
Kiser, John W.
338
90
Lewis, John J.
397
5, 105
Kisler, Bron Witt
123
40
Lewis-Hall, Freda
208
59
85
Li, Fumin
417
113
Li, Ning
261
72
Kitchens, William
Klein, Agnes V.
316
13, 46, 66
389
203, 415
41, 103
84
103
57, 112
Kleppinger, Cynthia
240
67
Li, Xiaoming
322
86
Kline Leidy, Nancy
156
49
Liberti, Lawrence E.
212
60
Klinger, Ety
422
114
Liebowitz, Jay
392
104
Klink, Gizzy
228
64
Lim, Robyn R.
383
101
Koch, Gary G.
118
39
Lin, Chih-Hwa Wallace
Kochan, Robert George
204
58
Lin, Hsien-Yi
Koerner, Chin
225
12, 63
Lipset, Craig H.
Plenary
34
Kokomoor, Kris
358
95
Lisman, John A.
252
70
Kondo, Tatsuya
368
98
Litwack, E. David
378
100
Kraenzlein, Joerg F.
160
50
Litwin, Jeff
Kravchenko, Andrei
173, 326
53, 87
Livesey, Michele
127
162, 212, 339
339
50, 60, 90
90
Program Committee
12
Board of Directors
13
Speaker Index
Speaker Name
Session No.
Loew, Brian
370
Logan, Brent
Lumpkin, Murray M.
Page No.
Speaker Name
Session No.
98
Meyer, Robert J.
258
71
Meyerson, Laura J.
118
38
139
44
Meyerson-Hess, Nancy
348
93
Lundy, J. Jason
223
62, 63
Midthun, Karen
369
98
Luttmann, Mark A.
390
103
Milford, Robert Johnalan
301
81
Lynn, Steven
341
91
Miller, Dan
420
114
Mahoney, Christie
311
83
Milligan, Sandra A.
Malla, Amy
Mallory, Kerri M.
224, 360
63, 96
97
240
67
Mitchel, Jules T.
Malloy, Kellie
241
67
Mitchell, C. Latham
Mandziuk, Kathleen A.
256
71
Moench, Elizabeth A.
12, 58, 75
12, 13
366
48
Program Committee, Board of Directors
50
Mills, Juliane
151
Mangum, Barry
161
Page No.
Molzon, Justina A.
12, 47
126, 152
41, 48
333, 413, 425
328
89, 112, 115
Manning, Donald C.
109
36
Monteath, Gareth Julian
Manning, Erica Kay
264
73
Moore, Christine M. V.
Mansfield, Elizabeth A.
250
70
Morefield, Elaine
March, John
117
38
Morrison, Royce A.
107, 157
Marchenko, Olga V.
423
114
Mozzicato, Patricia
356
95
115
88
12, 45, 72
38
36, 49
Marcussen, Mauricha F.
175
54
Mudgett, Daniel F.
285
77
Markson, Leona E.
212
60
Mulcahy, Lisa D.
273
75
Marlborough, Michelle
219
62
Mulder, Chris J. J.
252
70
Marquis, Dennis Edward
102
34
Mulder, Jacques
129
42
Mulinde, Jean
140
45
Marrone, Christopher M. Program Committee, 272, 365
12, 75, 97
Martin, Craig
306
82
Mulligan, George J.
306
82
Martorelli, Michael A.
220
62
Murao, Noriaki
149
47
Mascaro, Guy Andre
105
35
Murray, Mary S.
173
53
Massud, Joao
173
53
Muyl, J.C.
355
94
Mathis, Lisa L.
225
63
Mylenski, Tara
106
35
Matlis, Daniel R.
251
70
Myles, Jane E.
126
41
Matsumoto, Hiromi
385
102
Nable, Julia
370
98
Mauri, Kristin
154
48
Nalubola, Ritu
307
82
Maxemow, Dawn Pirozzi
418
113
Nasr, Moheb M.
142
45
Mayewski, Richard
126
41
Nearing, Toni-Marie
230
64
McAuslane, Neil
162, 336
Nel, Annalene
119
39
McCamish, Mark
384
102
Nelson, Bridgid
345
92
McCullough, Neil
253
70
Nessly, Michael
214
60
McKay, Lisa
253
70
Neyarapally, George
169
52
McKenney, John C.
276
75
Ng, Elizabeth
104
35
McLaughlin, Shiela
363
96
Nicholls, Graham J.
248
69
McMullen, Jeffrey P.
245
5, 68
Nichols, Robert
416
112
Meeker-O’Connell, Winifred Ann 167, 256, 282
50, 90
51, 52, 71, 77
Nick, Cecil J.
12, 76
12, 110
Mehra, Munish
Nishino, Junichi
173
53
Mehta, Nikhil
384
101
Noel, Rebecca A.
336
90
Mele, Joy
267
74
Nolan, Frances E.
Merryfield, Jessica
132
43
Norquist, Josephine M.
159
49, 50
Metcalf, Marilyn A.
108
36
Ohlssen, David
367
97
128
12, 50, 69
Speaker Index
Speaker Name
Ohura, Catherine
Session No.
Program Committee
Page No.
Speaker Name
12
Pierre, Christine K.
Session No.
217
Page No.
61
Okwesili, Paul
267
74
Pierre, Jan Holladay
301
81
Olenzak, Tom
251
70
Pines, Wayne L.
332
89
Oleske, Denise M.
145
46
Pinheiro, Jose C.
411, 423
Oliveria, Susan
117
38
Pinheiro, Simone P.
388
102, 103
Ono, Yoshihiko
421
114
Pissott Reig, Linda
228
64
Oransky, Ivan
222
62
Plante, David
358
95
Orri, Miguel
133
43
Poland, John
114
37
Oye, Kenneth
383
101
Pomerantz, Paul
Plenary
34
O’Brien, Michael J.
376
99
Poropatich, Ronald K.
133
43
O’Meara, Tara
262
72
Portman, Ronald
225
63
Paarlberg, Robert
276
75
Powell, Marjorie E.
397
5, 105
Palanjian, Shaghig
Program Committee
12
Powers, John H.
206, 265
58, 73
Palmer, Michael
414
112
Prado, Daniel
326
87
Paone, Antoinette
230
64
Price, Gil
213
60
Papadopoulos, Elektra Johanna
335
89
Price, Karen Lynn
367
97
Papaluca-Amati, Marisa
250
70
Pridgen, Renee
378
100
Parent, Keith M.
249
69
Przekop, Penelope
363
96
Pariser, Anne R.
346
92
Purcell, Thomas J.
418
113
Quaintance, Kim M.
Park, Min Soo
274, 323
Park, Soo Jin
209
59
Quinlan, Judith A.
371
98
Program Committee
13
Rabin, Olivier
390
103
Pasirstein, David
416
113
Radley, David
322
86
Patel, Kinnari
359
95
Rago, Lembit
136, 386
Patel, Nitin R.
201
57
Rahjou-Esfandiary, Leyla
209
59
Patrick, Donald L.
335
89
Rajaram, Ravi
334
89
Paty, Jean
310
83
Rao, Gayatri R.
149
47
Paul, Kala L.
342
91
Rasi, Guido
Paul, Pradip K.
286
78
Rassen, Jeremy
321
86
Peddicord, Douglas J.
245
5, 68
Ray, Amrit
330
5, 88
Pelton, Nye G.
101
34
Ray, Peter
104
35
Pennline, Kenneth J.
378
100
Parmentier, James
75, 87
111, 114
Raymond, Stephen A.
120, 139
12, 36
44, 102
39, 45
12, 36
Pepe, Matthew
412
111
Redding, Karen Jane
273
75
Pepe, Sondra A.
372
98
Reddy, David
330
5, 88
Perkins, David Ryan
355
94
Reed, Terrie
394
104
Perkins, Louise
306
82
Reggi, David Richard
153
48
Perry, Warren
409
111
Reichman, Marsha E.
232
65
Persinger, Charles
201
57
Rengarajan, Badri
243
68
Peterson, Barry T.
239
66
Reul, Todd Charles
281
77
Peterson, Ted
224
63
Reynolds, Robert
117, 321
Pezalla, Edmund
305
82
Rhiner, Lisa
374
99
Pfister, Marc
130
42
Ribar, Marija
350
93
Phelan, Timothy M.
154
48
Richards, Margaret S.
Phillips, Lawrence
108, 172
Richardson, Peter J.
134
43
Ridgewell, Richard
405
110
Pierchala, Lisa
418
36, 53
113
129
38, 86
12, 46
Speaker Index
Speaker Name
Riggins, Jennifer L.
Session No.
Page No.
Speaker Name
Session No.
Page No.
Board of Directors
13
Schuemie, Martijn
257
Rivera, Jesús
236
66
Schultz, Daniel G.
164
51
Roach, Michael C.
348
93
Schwartz, J. Sanford
319
85
Robb, Melissa A.
109
36
Schwartz, Steven P.
160
50
Robb, William
305
82
Scott-Lichter, Diane
222
62
Robbins, Michael
309
83
Sechler, Jan
131
42
Roberts, John A. (Jay)
Board of Directors
13
Seguine, Edward Stephen
Robinson, Constance
313
84
Shahzad, Aamir
Robinson, Janet E.
141
45
102, 215, 420
71
34, 61, 114
119, 204
39, 58
Sharbaugh, William J.
245
5, 68
Rocca, Mitra
287
78
Sharlin, Joshua
325
87
Rochester, C. George
388
103
Sharp, Michele L.
379
100
Rockney, Tracy
379
100
Sherman, Jeffrey W.
Roder, Beate
333
89
Shevel, Steve
215
60
Rodriguez, William J.
121
39
Shillingford, John
246
68
Shnaydman, Vladimir
243
68
Shrikhande, Alka
153
48
Roenninger, Stephan Karl
Romano, Steven
Roper, Paulette V.
Rosario, Lilliam
Rose, Janet L. "Lucy"
Rose, Klaus
168, 211, 254, 364
52, 59, 70, 97
Patient Program
EXEC Program
7
288
78
Shultz, Leigh
63
Siddhanti, Suresh R.
347
92
Siegel, Jay P.
384
102
224
149, 225
12, 58, 83
47, 63
Sietsema, William K.
380, 402, 414
100, 101, 109, 112
Rosecrans, Heather
138
44
Sigler, Catherine
Rosenberg, Michael J.
220
62
Silva, Honorio
259, 323
72, 86
Rotelli, Matthew D.
266
73
Silverman, Ed
245
5, 68
Ruark, Keith
402
109
Simmonds, Heather
354
94
Ruberg, Stephen J.
118
38
Simmons, Scott A.
243
68
389
103
Ryan, Patrick
257, 321
Sable, Carole
147
47
Singh, Larisa Nagra
Safarian, Alek
376
99
Sager, Philip T.
315
84
Saint-Raymond, Agnès
121, 148
Salazar Fontana, Laura
422
Sall, Barry S.
112, 138
71, 86
Simon, Lee S.
39, 54
114
37, 44
171
12, 57
53
Board of Directors
13
Singh, Richa
382
101
Singh, Romi
304
82
Slack, Mary Ann
267
74
Smed, Marie
377
100
Smith, Alexander D.
350
93
Sankoh, Abdul J.
246
69
Smith, Jay B.
334
89
Sato, Junko
233
65
Smith, Michelle R.
303
81
Sauers, Michael A.
308
83
Smith, Nancy D.
Savidge, Paul James
116
38
Smith, Stacey
210
59
Sawant, Anil
341
91
Sobczyk, Mike
114
37
Scarazzini, Linda J.
170
53
Sobel, Rachel E.
117
38
Scheeren, Joseph C.
134, 307
Soikes, Raul
403
109
74
Sokol, Ronald J.
396
105
Schenk, Joseph
268
43, 82
413, 425
112, 115
Scher, David Lee
133
43
Sollano, Josephine A.
231
65
Schiemann, Peter
140
45
Solterbeck, Annie C.
380
101
Schifkovitz, David
111
37
Sonstein, Stephen A.
Student Forum, 259, 323
Schindler, Jerald S.
266
73
Soukup, Mat
411
111
Spargo, Tai
370
98
Schneider, Gregg
12, 68
130
33, 72, 86
Speaker Index
Speaker Name
Session No.
Spielberg, Stephen P.
Spindler, Per
Spreen, Paul D.
Page No.
208
Speaker Name
5, 59
Thomas, Patrick
Session No.
Program Committee
Page No.
12
Board of Directors
13
Thomas-Jones, Carolynn J. Program Committee, 259
203
57
Thompson, Brett Allen
424
13, 72
115
41, 77
Thompson, Stephen
337
90
Tillman, Donna-Bea
164
51
Tiplady, Brian
132
43
Sprenger, Kenneth J.
127, 282
Sridhara, Rajeshwari
258
71
Stafford, Paula Brown
245
5, 68
Staib, Eric
249
69
Tiwari, Ram
322, 367
86, 97
Stansbury, James P.
223
63
Tominaga, Toshiyoshi
174, 368
54, 98
Starrett, Raymond G.
362
96
Tonning, Joseph
170
52
Steigerwalt, Ronald W.
331
88
Topiwala, Purnima J.
355
94
Stemhagen, Annette
346
92
Torchio, Susan
352
93
Stergiopoulos, Stella
405
110
Touch, Alan J.
339
90
Stewart, Mary Gardner
Program Committee
12
Towler, Eric M.
375
99
Stier, Jennifer Abrams
215
60
Tracy, LaRee A.
344, 391
Stockbridge, Lisa L.
332
89
Tranotti, Katherine
151
48
Stodart, Fraser
136
44
Tresley, Richard M.
269
74
Program Committee
12
Trinks, Uwe P.
249
69
Stoltenborg, Janet
Stone, Patrick D.
325
87
Stossel, Thomas P.
397
5, 105
Strandberg, Ola
358
Strom, Shannon P.
92, 104
Trudeau, Jeremiah J.
239
66
Tsukamoto, Atsushi
328
88
95
Tulskie, William Anthony
306
82
337
90
U, Khin Maung
105
35
Stuart, Jeffrey N.
250
69
Uemura, Akio
421
114
Stuelpner, Janet
382
101
Ulatowski, Timothy Alan
164
51
Stürmer, Til
143
46
Ulrey, Daniel M.
241
67
Program Committee, Board of Directors
13
Unger, Thomas
383
101
Su, Ling
Sullivan, Linda B.
219
61, 62
Usiskin, Donna
251
70
Summar, Marshall
346
92
Utsumi, Hideo
368
98
Sun, John Z.
218
61
Uyama, Yoshiaki
340, 421
Sviglin, Helena
224
63
Valdez, Mary Lou
174
54
Swaminathan, Uma
247
69
Valentine, James E.
312
84
Swank, Kevin
334
89
Vali, Behrang
214
60
Vallow, Susan M.
239
66
Sweeney, Fergus
114, 167, 280, 317
Swidersky, Paul
141, 387
45, 102
Vandergriff, Jim L.
154
48
Swit, Michael A.
244
68
Van Dongen, Paul
112
37
Szerszeniewska, Malgorzata
376
100
Van Doren, Sally
275, 342
Tabata, Yorozu
233
65
Van Etten, Aaron
131
42
Takacs, Adrienne R.
129
42
VanTrieste, Martin
341
91
Tal-Singer, Ruth
156
49
Varawalla, Nermeen Y.
412
111
Tamiya, Kenichi
368
98
Vega, Jose M.
217
61
39, 102
Venitz, Jürgen
Program Committee
13
Tanui, Paul K.
Tariah, Ibim B.
Temple, Robert J.
119, 386
361
146, 234, 315,
357, 413, 425
37, 52, 76, 85
91, 114
96
46, 65, 85,
95, 112, 115
Thakur, Emily T.
226
63
Thangaraj, Venkatesan
358
95
131
75, 91
Verbois, S. Leigh
324
87
Verplancke, Philippe
207
58
Verreth, Wim
382
101
Vodra, William W.
316
85
Volkova, Nataliya
171
53
Speaker Index
Speaker Name
Session No.
Page No.
Speaker Name
Vollmar, Joachim
246
68
Xu, Nancy
von Rickenbach, Josef
245
5, 68
Voora, Deepak
378
100
Waidell, George
207
58
Yager, Jean
Walker, Alexander M.
169
52
Walker, Stuart
336
Waltz, Deborah A.
130
Page No.
42
Board of Directors
13
404
110
Board of Directors
13
Yakatan, Gerald J.
244
68
90
Yap, Jeffrey T.
204
58
229
64
Yen, Diane Rintzler
303
81
Wang, Jianan
261
72
Yeo, Jing Ping
218
61
Wang, Sue-Jane
146
46
Yetter, Robert A.
369
98
Ward, Mike D.
237, 339
Xu, Ning
Session No.
Xu, Xia
Yoder, Christian P.
349
93
Ward, Steven T.
338
66, 90
90
Yuan, Weishi
258
71
Warfel, Melonie
Program Committee
12
Yuzuk, Mark
302
81
Warfield, Douglas L.
360
96
Zacharias, Cynthia R.
240
67
Watkins, Melynda
122
39, 40
Zacharoff, Kevin
366
97
Watson, John
245
5, 68
Zamarriego, Jose
354
94
Weiler, John M.
206, 265
58, 73
Zane, Patricia A.
417
113
Weisman, Neil
216
Welch, Julia D.
Wenger, Andreas
61
Zawisza, Julie Anne
349
93
Zhang, Jenny
218
61
419
113
Zhao-Wong, Anna C.
170
52
Wentz, Suzanne
151
48
Zielinski, Anne M.
311
83
Wenzel, Keith W.
12, 109, 113
Zimmerman, Lisa
351
93
Wertheimer, Albert
Program Committee
13
Westrich, Kimberly
319
85
Whalen, Ed
344
92
Wheeler, William
157
49
Whiting, Elaine
136
44
Whitney, Karl D.
404
110
Whritenour, Jessica
221
62
Wickremsinhe, Enaksha
417
113
Board of Directors
13
Wiejowski, Sandra A.
271
74
Wiemelt, Anthony P.
375
99
Wilkins, H. Jeffrey
262
72
Willenberg, Kelly M.
372
98
Williams, Leslie
147
47
Williams, Rebecca J.
314
84
Wilson, John R.
281
77
Widler, Beat
Wilson, Stephen E.
214, 266
60, 73
Winchell, Terry
301
81
Winslow, Robert M.
355
94
Wirthumer-Hoche, Christa
148, 324
53, 87
Wise, Glenn
392
104
Woodworth, Thasia G.
389
103
Xoxi, Entela
419
113
Xu, Jack
155
49
132
116, 413, 425
38, 112, 115
Speaker Disclosure Statements
SPEAKER DISCLOSURE STATEMENTS
(As of May 9, 2012)
No Relationship or Conflicts of Interest (Nothing to Disclose)
Thomas Abrams
Paul Brown
Peggy Coyle
Jason Ferla
Andrew Adams
Joan Buenconsejo
Lindsay Crampton
Luigi Ferrucci
Sunita Ahir
Gary Bufferd
Matthew Crowley
Kathleen Findlen
Vincent Ahonkhai
Paul Bunch
Celia Cruz
Gregory Fiore
Harry Alcorn
Laurie Burke
Constance Cullity
Harry Fisher
Crystal Allard
Keith Burkhart
Gerald Dal Pan
J. Michael Fitzmaurice
Cathryn Anderson
Allison Burmeister
Leslie Darling
Kelleen Flaherty
Diana Anderson
Tal Burt
Jeannie David
Alexander Fleming
Margaret Anderson
Laina Bush
Chris Davis
Frank Flöther
Yuki Ando
Gregory Busse
Melinda Davis
Pietro Folino Gallo
Jonathan Andrus
Molly Butler
Tim Davis
Michael Folkendt
Zoran Antonijevic
Rodney Butt
Xavier De Cuyper
Georges France
Patrick Archdeacon
Carol Bye
Luca De Nigro
Regina Freunscht
Yasuko Asahina
Patrick Caines
Marisa De Rosa
Patrick Frey
Nick Astley
Laurie Callen
Philip Dehazya
Kathleen Fritsch
Solomon Babani
Nicholas Cappuccino
Sandra Dennis
Shayesteh Fuerst-Ladani
Peter Bachmann
Anthony Carita
Jannell DePalantino
Mann Fung
Douglas Bain
Brooke Casselberry
Jean-Paul Deslypere
Sara Gagneten
Nyasha Bakare
Joy Cavagnaro
Savita Dhillon
Charles Ganley
Leslie Ball
Francesca Cerreta
Peter DiBiaso
Elizabeth Garrard
Kristina Barkhouser
Richard Chamberlain
Tim Dietlin
Andrew Garrett
Steven Bass
Joan Chambers
Joseph DiMasi
Skip Garrison
Nicole Bates
Michelle Charles
Kathleen Dolan
Cynthia Gates
Martin Bauer
Jennifer Charron
Jinhui Dou
Jamie Gault
Anne-Marie Baughn
Adam Chasse
John Doyle
Gary Gensinger
Ghiorghis Belai
Ray Chepesiuk
Marie Dray
Kenneth Getz
Danny Benau
Herng-Der Chern
Nancy Dreyer
Ashok Ghone
Barry Berger
Tiffany Cherry
Charles Drucker
Gary Gintant
Conny Berlin
Catherine Chew
Dinah Duarte
Barbara Gladson
Elise Berliner
Dhananjay Chhatre
Corey Dunham
Paul Glover
Deena Bernstein
Karla Childers
John Dunn
Barbara Godlew
Seth Berry
Leah Christl
Joseph Dustin
Gretchen Goller
Joseph Bertino
Joseph Cipollina
Beth Duvall
Gregg Goneconto
Ian Birks
Stephen Clark
Keiko Ebihara
Tara Gooen
Agustina Bisio
Catherine Clemons
Elaine Eborall
Rashmi Gopal-Srivastava
Lauren Black
David Clemow
Lauren Edelstein-Henry
Arik Gorban
Stella Blackburn
Aron Cogswell
Alan Edwards
Laura Governale
Larry Blankstein
Jean Cole
Andrew Eibling
Mark Gray
Carol Bognar
Linda Coleman
Hans-Georg Eichler
Melvyn Greberman
Katherine Bond
Suzanne Collins
Carla Epps
Yvonne Greenstreet
Scott Brand
Emer Cooke
Fritz Erni
Thomas Grundstrom
JoAnna Brodie
Karena Cooper
Joseph Famulare
Sunil Gupta
David Brodish
Timothy Cote
John Faulkes
Andrey Gurachevsky
Debby Brown
Patricia Cowall-Hanover
Michael Fauntleroy
Chad Gwaltney
Jackie Brown
Steven Cox
James Felli
Marlene Haffner
133
No Relationship or Conflicts of Interest (Nothing to Disclose), continued
Cindy Hahn
John Jenkins
Mark Leahey
Nancy Meyerson-Hess
Cynthia Hahn
Shun Jin
Young Jack Lee
Karen Midthun
William Hahn
Otis Johnson
Steven Lehrer
Robert Milford
Nader Halim
Luis Eduardo Johnson Rojas
S. Russ Lehrman
Dan Miller
Hilmar Hamann
Allen Jones
Patricia Leuchten
Juliane Mills
Tarek Hammad
Patrick Jordan
Ilyssa Levins
Jules Mitchel
Michael Hamrell
John Joseph
John Lewis
Elizabeth Moench
Rikki Hansen Bouchard
Connie Jung
Ning Li
Justina Molzon
Zia Haque
Kenneth Kaitin
Xiaoming Li
Gareth Monteath
Joan Harley
Aginus Kalis
Lawrence Liberti
Christine Moore
Kimberly Hartman
Robert Kane
Jay Liebowitz
Elaine Morefield
Martin Harvey-Allchurch
KR Karu
Robyn Lim
Lisa Mulcahy
Brett Hauber
Jeffrey Kasher
Chih-Hwa Wallace Lin
Jacques Mulder
Sandra Hecker
Sean Kassim
John Lisman
Jean Mulinde
Mark Hegarty
Nancy Katz
E. David Litwack
Noriaki Murao
Jonathan Helfgott
John Kauffman
Li-Ling Liu
Tara Mylenski
Jean Hendrickson
Margaret Keegan
Brent Logan
Ritu Nalubola
Matthew Henry
Cassandra Kennedy
Murray Lumpkin
Toni-Marie Nearing
Adrienne Hernandez
Ajay Keshava
J. Jason Lundy
Bridgid Nelson
Maureen Hess
Mansoor Khan
Mark Luttmann
George Neyarapally
Ben Heywood
Matthew Kiernan
Steven Lynn
Elizabeth Ng
Robert Hilke
Marci Kiester
Christie Mahoney
Robert Nichols
Ellen Hinkle
Ock-Joo Kim
Amy Malla
Cecil Nick
Freddie Ann Hoffman
Lynn King
Kathleen Mandziuk
Junichi Nishino
Michael Hoffman
John Kiser
Erica Manning
Michael O’Brien
Laura Hong
Bron Kisler
Elizabeth Mansfield
Catherine Ohura
Marcia Horn
William Kitchens
John March
Paul Okwesili
Christopher Hoyle
Agnes Klein
Olga Marchenko
Tom Olenzak
James Huang
Cynthia Kleppinger
Mauricha Marcussen
Ivan Oransky
Frank Hubbard
Gizzy Klink
Dennis Marquis
Kenneth Oye
Sherri Hubby
Gary Koch
Craig Martin
Robert Paarlberg
Kathy Hudson
Chin Koerner
Michael Martorelli
Michael Palmer
Earl Hulihan
Kris Kokomoor
Guy Mascaro
Antoinette Paone
Samuel Hume
Tatsuya Kondo
Lisa Mathis
Elektra Papadopoulos
H.M. James Hung
Andrei Kravchenko
Daniel Matlis
Marisa Papaluca-Amati
Virginia Hussong
Betty Kuhnert
Hiromi Matsumoto
Keith Parent
Melissa Hutchens
Darshan Kulkarni
Kristin Mauri
Anne Pariser
Martin Hynes
Rebecca Kush
Richard Mayewski
Min Soo Park
Telba Irony
Dimitri Kutsenko
Neil McAuslane
Soo Jin Park
John Isidor
Sandra Kweder
Neil McCullough
James Parmentier
Adam Istas
Graeme Ladds
Lisa McKay
Kinnari Patel
Teiki Iwaoka
Mary Jo Lamberti
Shiela McLaughlin
Donald Patrick
Ian Jackson
Mark Lanfear
Jeffrey McMullen
Douglas Peddicord
David Jacobson-Kram
Kelly Larrabee
Winifred Ann Meeker-O’Connell
Kenneth Pennline
Karen Jaffe
Peter Lassoff
Nikhil Mehta
Matthew Pepe
Nirdosh Jagota
Ian Lauf
Joy Mele
Louise Perkins
Brenda Jamerson
Lisa LaVange
Jessica Merryfield
Warren Perry
134
No Relationship or Conflicts of Interest (Nothing to Disclose), continued
Charles Persinger
Barry Sall
Linda Sullivan
Sue-Jane Wang
Ted Peterson
Junko Sato
Helena Sviglin
Mike Ward
Marc Pfister
Michael Sauers
Kevin Swank
Douglas Warfield
Lawrence Phillips
Linda Scarazzini
Fergus Sweeney
Melynda Watkins
Jan Pierre
Joseph Scheeren
Paul Swidersky
John Watson
Wayne Pines
Peter Schiemann
Michael Swit
Neil Weisman
Simone Pinheiro
Jerald Schindler
Malgorzata Szerszeniewska
Julia Welch
Ronald Poropatich
Gregg Schneider
Adrienne Takacs
Andreas Wenger
Marjorie Powell
Martijn Schuemie
Kenichi Tamiya
Suzanne Wentz
Gil Price
Steven Schwartz
Paul Tanui
Kimberly Westrich
Renee Pridgen
Diane Scott-Lichter
Ibim Tariah
Karl Whitney
Penelope Przekop
Jan Sechler
Robert Temple
Enaksha Wickremsinhe
Thomas Purcell
Aamir Shahzad
Emily Thakur
H. Jeffrey Wilkins
Judith Quinlan
William Sharbaugh
Venkatesan Thangaraj
Kelly Willenberg
Olivier Rabin
Joshua Sharlin
Carolynn Thomas-Jones
Rebecca Williams
David Radley
Steve Shevel
Stephen Thompson
Stephen Wilson
Lembit Rago
Vladimir Shnaydman
Ram Tiwari
Terry Winchell
Leyla Rahjou-Esfandiary
Alka Shrikhande
Toshiyoshi Tominaga
Christa Wirthumer-Hoche
Ravi Rajaram
William Sietsema
Joseph Tonning
Entela Xoxi
Gayatri Rao
Honorio Silva
Susan Torchio
Jack Xu
Guido Rasi
Ed Silverman
Eric Towler
Nancy Xu
Jeremy Rassen
Heather Simmonds
LaRee Tracy
Jing Yeo
Terrie Reed
Richa Singh
Katherine Tranotti
Robert Yetter
David Reggi
Romi Singh
Uwe Trinks
Christian Yoder
Marsha Reichman
Mary Ann Slack
Atsushi Tsukamoto
Weishi Yuan
Todd Reul
Marie Smed
William Tulskie
Mark Yuzuk
Lisa Rhiner
Jay Smith
Khin U
Kevin Zacharoff
Marija Ribar
Michelle Smith
Akio Uemura
Jose Zamarriego
Peter Richardson
Nancy Smith
Daniel Ulrey
Patricia Zane
Jesus Rivera
Stacey Smith
Donna Usiskin
Julie Zawisza
Michael Roach
Mike Sobczyk
Hideo Utsumi
Jenny Zhang
Melissa Robb
Raul Soikes
Yoshiaki Uyama
Anna Zhao-Wong
Constance Robinson
Annie Solterbeck
Mary Lou Valdez
Lisa Zimmerman
Janet Robinson
Stephen Sonstein
James Valentine
Mitra Rocca
Mat Soukup
Behrang Vali
C. George Rochester
Tai Spargo
Paul Van Dongen
Beate Roder
Stephen Spielberg
Sally Van Doren
William Rodriguez
Paul Spreen
Jim Vandergriff
Stephan Roenninger
Rajeshwari Sridhara
Nermeen Varawalla
Paulette Roper
Eric Staib
S. Leigh Verbois
Lilliam Rosario
James Stansbury
William Vodra
Janet L. “Lucy” Rose
Raymond Starrett
Joachim Vollmar
Michael Rosenberg
Jean Steckler
Deepak Voora
Keith Ruark
Stella Stergiopoulos
George Waidell
Alek Safarian
Lisa Stockbridge
Alexander Walker
Agnès Saint-Raymond
Ola Strandberg
Stuart Walker
Laura Salazar Fontana
Janet Stuelpner
Deborah Waltz
135
Disclosure Statements (as of May 9, 2012)
Following are the disclosures received by press time, May 9, 2012. Disclosure statements received after this date will be listed on the Addendum that is included
in the meeting materials distributed on site.
Valdo Arnera
OTHER SUPPORT - Employee of PHT Corporation
Thomas Casola
Lillian Auberson
STOCK SHAREHOLDER - Actelion Pharmaceuticals
Ltd, OTHER SUPPORT - Employee of Actelion
Pharmaceuticals Ltd
STOCK SHAREHOLDER - Merck & Co., Inc., Shire
Specialty Pharm
Nancie Celini
CONSULTANT - Employee of CAB inc.
Soledad Cepeda
STOCK SHAREHOLDER - Johnson & Johnson,
OTHER SUPPORT - Employee of Janssen PRD
Antoinette Azevedo
OTHER SUPPORT - Employee of
e-SubmissionsSolutions.com and Sage Submissions
Raghu Chintala
OTHER SUPPORT - Employee of ICON Plc
William Baker
OTHER SUPPORT - Employee of Cape Cod Clinical
Research, Inc.
Cyril Clarke
STOCK SHAREHOLDER - ICON PLC , OTHER
SUPPORT - Employee of ICON PLC
Lori Ball
STOCK SHAREHOLDER - Biostorage Technologies,
OTHER SUPPORT - Biostorage Technologies
Barton Cobert
Soo Bang
STOCK SHAREHOLDER - Celgene Corporation
STOCK SHAREHOLDER - Merck & Co., Inc., Pfizer
Inc, CONSULTANT - Affymax, Auxilium, Boehringer
Ingelheim, Columbia Labs
Roy Baranello
STOCK SHAREHOLDER - Pfizer Inc
Samuel Cohen
Kathleen Basmadjian
OTHER SUPPORT - Employee of Johnson & Johnson
Richard Bayney
STOCK SHAREHOLDER - Bristol-Myers Squibb,
Johnson & Johnson
CONSULTANT - Arean, Astellas, Biogen Idec,
Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi
Sankyo, Dainippon Sumitomo, Hyperion, Johnson
& Johnson, Medicis, Merck & Co., Inc., sanofi-aventis,
Takeda
Annetta Beauregard
OTHER SUPPORT - EMD Serono
Preciosa Coloma
GRANT SUPPORT - European Commission Seventh
Framework Programme (FP7/2007-2013)
Tracy Beck
STOCK SHAREHOLDER - Eli Lilly and Company,
OTHER SUPPORT - Employee of Eli Lilly and
Company
Jill Conner
STOCK SHAREHOLDER - Teva Pharmaceutical
Industries, Ltd., OTHER SUPPORT - Employee of
Teva Pharmaceutical Industries, Ltd.
Gesine Bejeuhr
OTHER SUPPORT - Employee of vfa Researchbased Pharmaceutical Companies
Michael Connolley
Donald Berry
STOCK SHAREHOLDER - Co-owner Berry
Consultants, CONSULTANT - Co-owner Berry
Consultants
STOCK SHAREHOLDER - Abbott, Eli Lilly and
Company, GlaxoSmithKline, Merck & Co., Inc.,
Johnson & Johnson, OTHER SUPPORT - Employee
of Daiichi Sankyo
David Cram
Bruce Binkowitz
STOCK SHAREHOLDER - Merck & Co., Inc.
Maarten Boers
OTHER SUPPORT - Member of OMERACT exec.
STOCK SHAREHOLDER - Allergan, Inc., GRANT
SUPPORT - Allergan, Inc., OTHER SUPPORT Allergan, Inc.
Marc Boutin
OTHER SUPPORT - Employee of National Health
Council
Anne Cropp
Yasmin de Faria Krim
Linda Bowen
STOCK SHAREHOLDER - Sanofi, OTHER SUPPORT
- Employee of Sanofi
Susanna Del Signore
Nancy Brandenburg
STOCK SHAREHOLDER - Celgene Corporation
Cari Deloa
John Breeden
OTHER SUPPORT - Employee of Philips Respironics
STOCK SHAREHOLDER - Genentech/Roche,
OTHER SUPPORT - Employee of Genentech/Roche
Michael Brennan
STOCK SHAREHOLDER - Johnson & Johnson
James DeSanti
STOCK SHAREHOLDER - PharmaVigilant
Bonnie Brescia
STOCK SHAREHOLDER - BBK Worldwide, OTHER
SUPPORT - Employee of BBK Worldwide
Joseph DiCesare
STOCK SHAREHOLDER - Novartis Pharmaceuticals
Corp, OTHER SUPPORT - Employee of Novartis
Frank Bretz
STOCK SHAREHOLDER - Novartis, OTHER
SUPPORT - Novartis
Colleen Dixon
STOCK SHAREHOLDER - Baxter Healthcare,
OTHER SUPPORT - Employee of MedImmune
Jeffrey Brown
GRANT SUPPORT - FDA, ONC, AHRQ
Donna Dorozinsky
CONSULTANT - Cape Cod Clinical Research, Inc.
Andreas Brueckner
STOCK SHAREHOLDER - Algeta, Amylin, Biogen,
Bayer, Elan, Elli Lilly and Company, Novartis
Vladimir Dragalin
STOCK SHAREHOLDER-Pfizer Inc
Marcus Droege
STOCK SHAREHOLDER - Baxter, Teva
Jonca Bull
STOCK SHAREHOLDER - Novartis
Carlos Dufeu
Linda Burdette
STOCK SHAREHOLDER - Hoffmann La-Roche
William DuMouchel
OTHER SUPPORT - Oracle Health Sciences
Bill Byrom
OTHER SUPPORT - Employee of Perceptive
Informatics
Ken Duncan
STOCK SHAREHOLDER - GlaxoSmithKline
Eric Easom
Pamela Campbell
STOCK SHAREHOLDER - EMC
OTHER SUPPORT - Employee of Anacor
Pharmaceuticals
Michael Cantor
OTHER SUPPORT - Employee of Pfizer Inc
Donna Ellender
Daniel Carlat
OTHER SUPPORT - Former CEO & President of
Carlat Publishing
Steven Elliott
STOCK SHAREHOLDER - AstraZeneca, OTHER
SUPPORT - Employee of AstraZeneca
STOCK SHAREHOLDER - Amgen Inc, CONSULTANT
- Amgen Inc
Andrew Emmett
OTHER SUPPORT - Employee of Biotechnogy
Industry Organization
Kevin Carroll
136
Disclosure Statements (as of May 9, 2012), continued
Sylvia Engelen
OTHER SUPPORT - Employee of Bayer HealthCare
Suzana Griffin
Robert Epstein
OTHER SUPPORT - Employee of Medco Health
Solutions (MHS) and United BioSource Corp
(Medco subsidiary)
STOCK SHAREHOLDER - Amgen Inc., OTHER
SUPPORT - Employee of Amgen Inc.
Eric Grinstead
Company
STOCK SHAREHOLDER - Synageva BioPharma,
OTHER SUPPORT - Employee of Synageva
BioPharma
Jeannine Hanson
STOCK SHAREHOLDER - Amgen
Christopher Harbison
STOCK SHAREHOLDER - Alexza Pharmaceuticals,
Amgen, CONSULTANT - Amarin Corporation,
Pfizer Inc
OTHER SUPPORT - Bristol-Myers Squibb
Peter Harpum
OTHER SUPPORT - Affiliate Professorship,
Grenoble EdM, CONSULTANT - DCRI,
GlaxoSmithKline, Novartis, Regeneron, Vifor
Douglas Faries
David Feigal
John Finkle
Kim Fookes
STOCK SHAREHOLDER - Takeda
Judy Harrison
CONSULTANT - MedDRA MSSO
Edward Fotsch
OTHER SUPPORT - CEO of PDR Network
Steve Hasler
CONSULTANT - CSC Inc
Betsy Fritschel
Clarice (Risa) Hayes
STOCK SHAREHOLDER - Eli Lilly and Company
Richard Heaslip
Yoshikata Furuya
OTHER SUPPORT - MSD K.K.
STOCK SHAREHOLDER - Pfizer Inc, OTHER
SUPPORT - Employee of Programmatic Sciences
Owen Garrick
STOCK SHAREHOLDER - Bridge Clinical Research
Alan Hochberg
Helle Gawrylewski
OTHER SUPPORT - Employee of F. HoffmanLaRoche, Ltd.
Brenda Gaydos
Company
Stephen Holcroft
Jon Holmlund
STOCK SHAREHOLDER - Life Technologies, OTHER
SUPPORT - Patent holder--Ascenta Therapeutics,
CONSULTANT - ClinDatrix/Cellerant, Prometheus,
Seattle Genetics
Florence Houn
STOCK SHAREHOLDER - Abbott, Celgene
Natalie Gearhart
STOCK SHAREHOLDER - Janssen, OTHER
SUPPORT - Employee of Janssen
Stewart Geary
STOCK SHAREHOLDER - Eisai Co., Ltd., OTHER
SUPPORT - Eisai Co., Ltd.
John Humphreys
Art Gertel
STOCK SHAREHOLDER - Amgen, Merck & Co., Inc. ,
OTHER SUPPORT - Beardsworth Consulting Group,
Inc.
Informatics
Richard Hutchins
Michael Ibara
Thomas Getzen
GRANT SUPPORT - Society of Actuaries, OTHER
SUPPORT - J. Wile & Sons
Ekopimo Ibia
STOCK SHAREHOLDER - Merck & Co., Inc., OTHER
SUPPORT - Employee of Merck & Co., Inc.
Jennifer Giangrande
OTHER SUPPORT - Employee of Hoffmann La
Roche Inc.
Anne Marie Inglis
OTHER SUPPORT - Employee of GlaxoSmithKline
Michael Irizarry
STOCK SHAREHOLDER - GlaxoSmithKline, OTHER
SUPPORT - Employee of GlaxoSmithKline
Robert Jacobs
STOCK SHAREHOLDER - SCYNEXIS, Inc., OTHER
SUPPORT - SCYNEXIS, Inc.
Sue James
Michael Jay
OTHER SUPPORT - Employee of RxTrials
Jeffrey Gibbs
OTHER SUPPORT - Employee of Hyman Phelps &
McNamara, PC
Cynthia Girman
STOCK SHAREHOLDER - Merck & Co., Inc, OTHER
SUPPORT - Merck & Co., Inc
Richard Gliklich
OTHER SUPPORT - Employee of Quintiles
William Gluck
STOCK SHAREHOLDER - DATATRAK International
Robert Glynn
GRANT SUPPORT - AstraZeneca, Novartis,
CONSULTANT - Merck & Co., Inc.
Kristin Goettner
Charles Gombar
STOCK SHAREHOLDER - Endo, Pfizer Inc
Carl Gommoll
STOCK SHAREHOLDER - Forest Laboratories, Inc.
Carmen Gonzalez
OTHER SUPPORT - Employee of Healthcare
Communications Group
Jody Green
OTHER SUPPORT - Employee of Rocky Mountain
Poison and Drug Center
John Greist
STOCK SHAREHOLDER - Healthcare Technology
Systems, GRANT SUPPORT - AstraZeneca, Eli
Lilly and Company, Pfizer Inc, Takeda, UCB,
CONSULTANT - Eli Lilly and Company, Otsuka,
Pfizer Inc, Transcept
Kenneth Grice
STOCK SHAREHOLDER - Bayer, OTHER SUPPORT Bayer HealthCare
Janet Jenkins-Showalter STOCK SHAREHOLDER - Roche/Genentech
137
Merete Joergensen
STOCK SHAREHOLDER - Novo Nordisk A/S,
NovoZymes A/S, OTHER SUPPORT - Novo Nordisk
A/S
James Johnson
OTHER SUPPORT - UCB BioSciences
Steve Jolley
CONSULTANT - SJ Pharma Consulting
Jonathan Kafer
OTHER SUPPORT - Employee of Teva
Pharmaceuticals
John Kamp
STOCK SHAREHOLDER - Amylin, Beckton
Dickinson, Bristol-Myers Squibb, Celgene,
Cumberland, Enzo, Exelixis, GE, Healthways, IPG,
Johnson & Johnson, Medicus, Medtronic, Novo
Nordisk, Omnicom, Publicis, Scolr, Sucampo, Target,
Teva, United Therapeutics, Vertex, Walgreens,
Walmart, WPP, OTHER SUPPORT - Exec Dir of
Coalition for Healthcare Communication
Becki Kanjirathinkal
OTHER SUPPORT - Employee of CNA Insurance
Abdulkadir Keskinaslan OTHER SUPPORT - Employee of Novartis Pharma
AG
Laura Meyerson
STOCK SHAREHOLDER - Biogen Idec, Johnson &
Johnson, Merck & Co., Inc.
Martin Kimber
CONSULTANT - Employee of Tessella plc
Sandra Milligan
Nelson Kinnersley
OTHER SUPPORT - Employee of Roche
Pharmaceuticals
C. Latham Mitchell
Royce Morrison
Nancy Kline Leidy
OTHER SUPPORT - Employee of United BioSource
Corporation (UBC)
OTHER SUPPORT - Employee of Comprehensive
Patricia Mozzicato
OTHER SUPPORT - Employee of MedDRA MSSO
Ety Klinger
CONSULTANT - Teva
Daniel Mudgett
STOCK SHAREHOLDER - Medidata Solutions, Inc.
Robert Kochan
OTHER SUPPORT - Covance Inc.
Chris Mulder
Joerg Kraenzlein
OTHER SUPPORT - Cliniworks and iSOFT are
partners
GRANT SUPPORT - AstraZeneca, DSM Food
Specialties, Extended Life Medicine, Fuji, Janssen
Cilag, NIPED, Nycomed
Tatsuo Kurokawa
GRANT SUPPORT - Otsuka Pharmaceuticals,
Shionogi Pharmaceuticals, Taisho Pharmaceuticals,
CONSULTANT - Torey
George Mulligan
OTHER SUPPORT - Employee of Millennium
Pharmaceuticals
Mary Murray
OTHER SUPPORT - Employee of Bristol-Myers Squibb
Graham Lappin
STOCK SHAREHOLDER - Xceleron Ltd
J.C. Muyl
STOCK SHAREHOLDER - C3i
Catherine Lee
OTHER SUPPORT - Pfizer Inc
Jane Myles
STOCK SHAREHOLDER - Roche
Andy Lee
STOCK SHAREHOLDER - sanofi, OTHER SUPPORT
- Employee of sanofi
Julia Nable
CONSULTANT - NORD, Synageva
Moheb Nasr
J. Steven Leeder
GRANT SUPPORT - National Institutes of Health
STOCK SHAREHOLDER - Employee of
GlaxoSmithKline
Barbara Leishman
STOCK SHAREHOLDER - Roche, OTHER SUPPORT Employee of Roche
Annalene Nel
OTHER SUPPORT - Employee of International
Partnership For Microbicides
Daniel Lenihan
GRANT SUPPORT - Acorda, Inc., CONSULTANT AstraZeneca, Roche
Michael Nessly
STOCK SHAREHOLDER - Merck & Co., Inc., Shire
Graham Nicholls
Amy Leong
CONSULTANT - GlaxoSmithKline, Health Focus Media
OTHER SUPPORT - Employee of Almac Clinical
Technologies
Bennett Levitan
Rebecca Noel
Freda Lewis-Hall
Company
Fumin Li
OTHER SUPPORT - Employee of Covance
Laboratories
Frances Nolan
STOCK SHAREHOLDER - Medidata Solutions
Josephine Norquist
Craig Lipset
STOCK SHAREHOLDER - Merck Sharpe & Dohme,
Corp.
Jeffrey Litwin
STOCK SHAREHOLDER - ERT
David Ohlssen
STOCK SHAREHOLDER - Novartis
Brian Loew
OTHER SUPPORT - Spouse employee of Merck &
Co., Inc.
Denise Oleske
Kerri Mallory
OTHER SUPPORT - GlaxoSmithKline
STOCK SHAREHOLDER - Abbott Laboratories,
OTHER SUPPORT - Employee of Abbott
Laboratories
Kellie Malloy
OTHER SUPPORT - Employee of PharmaNet/i3
Susan Oliveria
OTHER SUPPORT - Employee of EpiSource
Barry Mangum
CONSULTANT - Abbott, Pfizer Inc
Tara O’Meara
STOCK SHAREHOLDER - Synageva BioPharma Corp.,
OTHER SUPPORT - Synageva BioPharma Corp.
Leona Markson
STOCK SHAREHOLDER - Merck Sharp & Dohme
Corp., OTHER SUPPORT - Employee of Merck
Sharp & Dohme Corp.
Yoshihiko Ono
SUPPORT - Employee of Pfizer Japan Inc.
STOCK SHAREHOLDER - Medidata Solutions
Miguel Orri
Christopher Marrone
Company
Shaghig Palanjian
STOCK SHAREHOLDER - PAREXEL International,
Shire HGT
David Pasirstein
Joao Massud
OTHER SUPPORT - Employee of Trials Consulting
Nitin Patel
STOCK SHAREHOLDER - Cytel Inc.
Dawn Maxemow
OTHER SUPPORT - Employee of INC Research, Inc.
Jean Paty
STOCK SHAREHOLDER - invivodata, inc.
Mark McCamish
OTHER SUPPORT - Employee of Sandoz
International
Pradip Paul
STOCK SHAREHOLDER - Sanofi
Kala Paul
CONSULTANT - BioSect2, Gilead, Pfizer Inc, UBC
John McKenney
STOCK SHAREHOLDER - SEC Associates, Inc.
Nye Pelton
Munish Mehra
STOCK SHAREHOLDER - Global Drug
Development, Quantum BioPharma, OTHER
SUPPORT - Principal of Global Drug Development,
Principal of Quantum BioPharma
STOCK SHAREHOLDER - Employee of Eli Lilly and
Company
Sondra Pepe
STOCK SHAREHOLDER - Medidata Solutions, Inc.
David Perkins
STOCK SHAREHOLDER - Sanofi
Barry Peterson
OTHER SUPPORT - Employee of Philips Respironics
Michelle Marlborough
Marilyn Metcalf
138
Disclosure Statements (as of May 9, 2012), continued
Edmund Pezalla
STOCK SHAREHOLDER - Aetna, OTHER SUPPORT
- Employee of Aetna
Timothy Phelan
Lisa Pierchala
OTHER SUPPORT - Employee of MMS Holdings Inc.
Christine Pierre
Jose Pinheiro
Joseph Schenk
CONSULTANT - QA Edge, Inc.
David Scher
OTHER SUPPORT - Boehringer-Ingelheim, Sanofi,
St Jude Medical, CONSULTANT - Happtique,
Medtronic, St Jude Medical
STOCK SHAREHOLDER - RxTrials & RxTi
David Schifkovitz
Novartis
Daniel Schultz
CONSULTANT - Employee of GreenLeaf Health, LLC
J. Sanford Schwartz
STOCK SHAREHOLDER - General Electric
Company, GRANT SUPPORT - Pfizer Inc,
CONSULTANT - Bayer, UBC
Linda Pissott Reig
OTHER SUPPORT - Employee of Buchanan
Ingersoll & Rooney
David Plante
OTHER SUPPORT - Aegerion Pharmaceuticals, Inc.
Edward Seguine
STOCK SHAREHOLDER - Clinical Ink
John Poland
STOCK SHAREHOLDER - Covance
Michele Sharp
Ronald Portman
OTHER SUPPORT - Employee of Bristol-Myers Squibb
Jeffrey Sherman
STOCK SHAREHOLDER - Horizon Pharma, OTHER
SUPPORT - Horizon Pharma
John Powers
CONSULTANT - Abbott, Gilead, Merck & Co., Inc.,
Pfizer Inc, Optimer, Trius
John Shillingford
OTHER SUPPORT - Employee of Aptiv Solutions
Daniel Prado
OTHER SUPPORT - Employee of ReSearch
Pharmaceutical Services, Inc.
Leigh Shultz
STOCK SHAREHOLDER - Merck & Co., Inc, OTHER
Karen Price
Company
Suresh Siddhanti
STOCK SHAREHOLDER - Amgen Inc, OTHER
SUPPORT - Employee of Amgen Inc.
Jay Siegel
Kim Quaintance
STOCK SHAREHOLDER - Eisai, Inc.
Catherine Sigler
Peter Ray
STOCK SHAREHOLDER - Bristol-Myers Squibb
Corporation
Amrit Ray
Scott Simmons
OTHER SUPPORT - Eli Lilly and Company
Stephen Raymond
STOCK SHAREHOLDER - PHT Corporation
Lee Simon
STOCK SHAREHOLDER - Savient Pharmaceutical
Karen Redding
STOCK SHAREHOLDER - Phlexglobal Ltd
Alexander Smith
CONSULTANT - Employee of ADS Pharma
Consulting LLC
David Reddy
OTHER SUPPORT - Employee of Medicines for
Malaria Venture
Rachel Sobel
SUPPORT - Employee of Pfizer Inc
Ronald Sokol
OTHER SUPPORT - Yasoo Health, Inc.,
CONSULTANT - Ikaria Inc.
Josephine Sollano
Kenneth Sprenger
Paula Stafford
STOCK SHAREHOLDER - Quintiles
Ronald Steigerwalt
Annette Stemhagen
Corporation
Mary Stewart
OTHER SUPPORT - Employee of H. Lundbeck A/S,
Spouse employee of NovoNordisk A/S
Jennifer Stier
STOCK SHAREHOLDER - Medidate, OTHER
SUPPORT - Employee of Medidata
Badri Rengarajan
OTHER SUPPORT - Employee of Archimedes, Inc.
Robert Reynolds
Margaret Richards
STOCK SHAREHOLDER - Genzyme Corp., PPD
Richard Ridgewell
STOCK SHAREHOLDER - Covance Laboratories Inc.
William Robb
STOCK SHAREHOLDER - Apple, B of A, Berkshire
Hathaway, General Electric,
Michael Robbins
OTHER SUPPORT - Employee of sanofi-aventis
Tracy Rockney
STOCK SHAREHOLDER - Abbott, OTHER SUPPORT
- Abbott
Steven Romano
STOCK SHAREHOLDER - Employee of Pfizer Inc
Klaus Rose
STOCK SHAREHOLDER - Novartis, Roche
Heather Rosecrans
CONSULTANT - Employee of GreenLeaf Health, LLC
Matthew Rotelli
Fraser Stodart
Stephen Ruberg
Company
Janet Stoltenborg
OTHER SUPPORT - Employee of AstraZeneca LLP
Patrick Stone
OTHER SUPPORT - Employee of TradeStone QA LLC
Thomas Stossel
CONSULTANT - Genentech
Shannon Strom
OTHER SUPPORT - Employee of Pearl Therapeutics
OTHER SUPPORT - Employee of Novartis
Pharmaceuticals Corporation
Patrick Ryan
OTHER SUPPORT - Employee of Jansen Research
and Development
Carole Sable
OTHER SUPPORT - Employee of Merck & Co., Inc.
Jeffrey Stuart
Philip Sager
OTHER SUPPORT - Employee of Sager Consulting
Experts
Til Stürmer
GRANT SUPPORT - GlaxoSmithKline, Merck & Co.,
Inc., Sanofi
Merck & Co., Inc.
Ling Su
SUPPORT - Employee of Novartis
STOCK SHAREHOLDER - Johnson & Johnson, Novo
Nordisk, Pfizer Inc, OTHER SUPPORT - Johnson &
Johnson
Marshall Summar
GRANT SUPPORT - NIH
John Sun
STOCK SHAREHOLDER - CPHI
Paul Savidge
Anil Sawant
139
GRANT SUPPORT - GlaxoSmithKline Biologicals,
OTHER SUPPORT - Employee of GlaxoSmithKline
Biologicals
John Wilson
STOCK SHAREHOLDER - Beaufort LLC
Robert Winslow
SUPPORT - Quintiles Transnational
Yorozu Tabata
OTHER SUPPORT-Employee of PwC PRTM
Glenn Wise
OTHER SUPPORT - Employee of PPD
Ruth Tal-Singer
Thasia Woodworth
Patrick Thomas
SUPPORT - Employee of GlaxoSmithKline
OTHER SUPPORT - Former employee of Novartis,
Pfizer Inc, Roche
Xia Xu
Brett Thompson
STOCK SHAREHOLDER - sanofi, OTHER SUPPORT
- sanofi
Gerald Yakatan
Donna-Bea Tillman
OTHER SUPPORT - Employee of Microsoft
STOCK SHAREHOLDER - IriSys, Inc., OTHER
SUPPORT - Employee of IriSys, Inc.
Brian Tiplady
SUPPORT - Employee of invivodata inc.,
CONSULTANT - Research consultancy in cognition
Jeffrey Yap
GRANT SUPPORT - Bayer, Bristol-Myers Squibb,
Pfizer, Toshiba, CONSULTANT - IBA
Diane Yen
OTHER SUPPORT - Employee of Merck & Co., Inc.
Purnima Topiwala
STOCK SHAREHOLDER - Johnson and Johnson,
OTHER SUPPORT - Employee of Janssen Scientific
Affairs
Cynthia Zacharias
OTHER SUPPORT - Employee of Celgene
Corporation
Anne Zielinski
Alan Touch
OTHER SUPPORT - Employee of INC Research, LLC
STOCK SHAREHOLDER - Medidata Solutions,
OTHER SUPPORT - Medidata Solutions
Richard Tresley
STOCK SHAREHOLDER - Abbott, Johnson &
Johnson, Merck & Co., Inc., OTHER SUPPORT Astellas, Employee of Abbott
Jeremiah Trudeau
OTHER SUPPORT - Employee of Analgesic
Solutions
Timothy Ulatowski
CONSULTANT - Altria, Becker and Associates,
GreenLeaf, NDA Partners, Quality Hub
Susan Vallow
Aaron Van Etten
OTHER SUPPORT - Employee of Amgen, Inc.
Jose Vega
STOCK SHAREHOLDER - Amgen, Inc., OTHER
SUPPORT - Employee of Amgen, Inc.
Uma Swaminathan
Jurgen Venitz
OTHER SUPPORT - Member Scientific Advisory
Board, AesRX, CONSULTANT - Allos, ARCA, Altria,
Elusys, Euthymics, External Expert FDA, Furiex,
Molecules for Health, Otsuka
Philippe Verplancke
STOCK SHAREHOLDER - XClinical GmbH, OTHER
SUPPORT - Employee of XClinical GmbH
Wim Verreth
OTHER SUPPORT - Employee of SGS LSS
Nataliya Volkova
Josef von Rickenbach
STOCK SHAREHOLDER - PAREXEL International
Corporation
Steven Ward
Company
John Weiler
STOCK SHAREHOLDER - CompleWare
Keith Wenzel
Informatics
Ed Whalen
William Wheeler
CONSULTANT - Celerion, Comprehensive Clinical
Develop
Elaine Whiting
SUPPORT - Employee of AstraZeneca
Sandra Wiejowski
OTHER SUPPORT - Abbott
Anthony Wiemelt
Leslie Williams
STOCK SHAREHOLDER - Hepregen, STOCK
SHAREHOLDER - ImmusanT Inc, OTHER SUPPORT
- Employee of ImmusanT Inc
The following PIM planners and managers, Laura Excell, ND, NP, MS, MA,
LPC, NCC; Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CCMEP;
Jan Schultz, RN, MSN, CCMEP; and Patricia Staples, MSN, NP-C, CCRN
hereby state that they or their spouse/life partner do not have any financial
relationships or relationships to products or devices with any commercial
interest related to the content of this activity of any amount during the past
12 months.
The following DIA planners and managers, Jennifer Andree-Webb; Susan
Cantrell; Julie Ho; Laura Parker; Paul Pomerantz; Holly Stevens; and Karen
Wetzel, hereby state that they or their spouse/life partner do not have any
financial relationships or relationships to products or devices with any
commercial interest related to the content of this activity of any amount
during the past 12 months. The DIA planner and manager, Maureen Lamplugh,
has disclosed that she is a stock shareholder of Medco and Merck & Co., Inc.
The following DIA Pharmacy Committee members have disclosed the
following: Alan Boyd, RPh, stock shareholder of CNS Vital Signs, LLC; David
Cocchetto, PhD, RPh, stock shareholder of GlaxoSmithKline, Teva; former
employee of GlaxoSmithKline; consultant to Cempra Pharmaceuticals,
Chimerix, Inc., and POZEN Inc.; Charles Depew, PharmD, stock shareholder
of GlaxoSmithKline; Teresa P. Dowling, PharmD, stock shareholder of
AstraZeneca and Merck & Co., Inc.; Truus Janse-de Hoog, PharmD, MSc,
no financial relationships; Monica Kwarcinski, PharmD, employee of
Purdue Pharma; Karin Mueller, PharmD, RPh, MBA, stock shareholder
of AstraZeneca and Wyeth; J. Christopher Prue, MBA, RPh, no financial
relationships.
The following project management professionals have disclosed the
following: Thomas R. Dunson, MBA, PMP, no financial relationships;
Cris Howard, MBA, MEd, PMP, stock shareholder of Emergent BioSolutions,
Johnson & Johnson, Merck & Co., Inc.; Leigh Shultz, PhD, PMP, stock
shareholder and other support Merck & Co., Inc.
140
Universal Activity Numbers
UNIVERSAL ACTIVITY NUMBERS
Below is a list of the pharmacy designated Universal Activity Number (UAN) and type of activity that is applicable for the following program offerings.
MONDAY, JUNE 25, 2012
Number
Title of Offering
Assigned UAN
Type of Activity
#108
Advancing Benefit-risk Visualization and Communication
286-12-000-506-L04-P
Knowledge
#109
New Ways to Learn What Happens to Patients AFTER Approval
286-12-000-507-L04-P
Knowledge
#110
Transforming Regulatory Information Into Actionable Regulatory Intelligence for Emerging Markets
286-12-000-508-L04-P
Knowledge
#111
Effective Switching from Rx to OTC Status: Maximizing Revenue and Profit From Off-Patent Products
286-12-000-509-L04-P
Knowledge
#112
Companion Diagnostics: Current and Future Developments
286-12-000-510-L04-P
Knowledge
#113
Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
286-12-000-523-L04-P
Application
#114
286-12-000-512-L04-P
Knowledge
#115
286-12-000-513-L04-P
Knowledge
#116
The Impact of Social Media on Product Promotion and Pharmacovigilance
286-12-000-514-L04-P
Knowledge
#117
Approaches to Postapproval Pediatric Safety Surveillance
286-12-000-515-L04-P
Knowledge
#118
Hot Topics in Statistics: Industry, CRO, Academic, and Regulatory Perspectives
286-12-000-516-L04-P
Knowledge
#134
286-12-000-517-L04-P
Knowledge
#139
Regulatory Collaboration/21st Century Innovation: Views of the Heads of Health Canada, the European
Medicines Agency, and the US FDA
286-12-000-518-L04-P
Knowledge
#140
Quality by Design: Is Your Clinical Trial Fit for Purpose?
286-12-000-519-L04-P
Knowledge
#143
Demystifying Approaches to the Design and Analysis of Observational Studies of Comparative Effectiveness
286-12-000-520-L04-P
Knowledge
#158
Communicating Drug Safety Information Using Social Media: FDA and Industry Perspectives
286-12-000-521-L04-P
Knowledge
#159
PRO Measurement in Clinical Trials: Need for Education and Training
286-12-000-522-L04-P
Knowledge
#165
286-12-000-511-L04-P
Knowledge
#169
Application of Quality of Evidence Assessment Tools to the Evaluation of Observational Pharmacoepidemiologic Studies
286-12-000-524-L04-P
Knowledge
#170
Electronic Health Records (EHR) and Medication Safety and Adherence
286-12-000-525-L04-P
Knowledge
TUESDAY, JUNE 26, 2012
Number
Title of Offering
Assigned UAN
Type of Activity
#206
Defining Study Endpoints in 2012: The Journey Continues
286-12-000-530-L04-P
Knowledge
#210
286-12-000-531-L04-P
Knowledge
#221
Skin-drug Biotransformation: What Testing Should We Do?
286-12-000-532-L04-P
Knowledge
#222
286-12-000-533-L04-P
Knowledge
#223
Labeling Claims Based on Patient-reported Outcome Measures: It Takes a Village!
286-12-000-534-L04-P
Knowledge
#224
Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery and Reinvestment Act Patient
Centered Outcomes Research) Data Standardization Efforts
286-12-000-535-L04-P
Knowledge
#226
286-12-000-536-L04-P
Knowledge
#227
286-12-000-537-L04-P
Knowledge
#228
286-12-000-538-L04-P
Knowledge
#231
The Effects of NICE Technology Assessments on Prescribing and Cost-sharing Behavior in the US
286-12-000-539-L04-P
Knowledge
#234
FDA Draft Guidance on Multiple Endpoints in Clinical Trials
286-12-000-540-L04-P
Knowledge
#236
286-12-000-541-L04-P
Application
#247
From Design to Disclosure: Pleasing Multiple Masters
286-12-000-543-L04-P
Knowledge
#248
Implementing Adaptive Clinical Trials: A Practical Perspective
286-12-000-544-L04-P
Knowledge
#249
Innovative Ways of Looking at Computer System Validation
286-12-000-545-L04-P
Knowledge
#252
Drug Rediscovery as an Innovative Tool to Meet Unmet Medical Needs
286-12-000-546-L04-P
Knowledge
#253
What Should You Put in a Clinical Quality Assurance (CQA) Agreement
286-12-000-547-L04-P
Knowledge
#255
Registries for Evaluating Patient Outcomes: Emerging Areas of Controversy
286-12-000-548-L04-P
Knowledge
#258
Noninferiority Trial Designs: Perspectives from Academia, Industry, and a Regulatory Agency
286-12-000-549-L04-P
Knowledge
#262
Understanding the Challenges of Conducting Studies for Orphan Indications and Rare Diseases
286-12-000-550-L04-P
Knowledge
#265
Beyond Taxonomy
286-12-000-551-L04-P
Knowledge
141
Universal Activity Numbers
#269
Cross-sector Innovation Brings Tailored Therapies to Patients
286-12-000-552-L04-P
Knowledge
#272
Evidence for the Marketplace: Bridging the Gap Between Industry, Payer, Providers, and Patients
286-12-000-553-L04-P
Knowledge
#279
Leveraging Technology in an Age of Readily Available Information
286-12-000-554-L04-P
Knowledge
WEDNESDAY, JUNE 27, 2012
Number
Title of Offering
Assigned UAN
Type of Activity
#308
286-12-000-556-L04-P
Application
#309
Implementing Structured Authoring: Understanding the DITA Model and Its Applicability for Content
and Metadata Management
286-12-000-557-L04-P
Application
#310
Combining Patient Self-report and Clinician Oversight: Are Two Heads Better than One?
286-12-000-558-L04-P
Knowledge
#315
Oncology Medications: State-of-the-art Identification and Management of Potential CV Safety Issues
During Development
286-12-000-559-L04-P
Knowledge
#316
Policy and Enforcement Trends: Are Regulators and Industry Heading in the Right Direction?
286-12-000-560-L04-P
Knowledge
#319
Environment for Health Care Decision Making: The Role of CER, Evidence-based Medicine, Quality, and Value
286-12-000-561-L04-P
Knowledge
#331
Can Human Carcinogenic Risk Be Communicated Without a Rodent Bioassay?
286-12-000-562-L04-P
Knowledge
#332
FDA Enforcement Update: Advertising and Promotion
286-12-000-563-L04-P
Knowledge
#335
Clinical Outcome Assessments in the Evaluation of Medical Products in Pediatrics
286-12-000-564-L04-P
Knowledge
#336
Building the Benefit-risk Toolbox: Is There a Consensus on a Scientifically Acceptable Framework?
286-12-000-565-L04-P
Knowledge
#340
Meeting the Therapeutic Needs of Older Patients: A Sustainable Collaborative Approach
286-12-000-566-L04-P
Knowledge
#341
Regulatory Updates on Current Trends in Drug Quality and Manufacturing
286-12-000-567-L04-P
Knowledge
#342
REMS: Are Our Written Communications Truly Mitigating Risks to Patients?
286-12-000-568-L04-P
Knowledge
#346
Natural History Studies for Rare Diseases and Orphan Conditions
286-12-000-569-L04-P
Knowledge
#354
286-12-000-570-L04-P
Knowledge
#356
What Medical Writers Need to Know about MedDRA
286-12-000-571-L04-P
Application
#357
Innovations Aimed at Improving Effectiveness and Speed of the Therapeutic Development Process
286-12-000-572-L04-P
Knowledge
#359
Orphan Drug Development: Global Regulatory Challenges and Initiatives
286-12-000-573-L04-P
Knowledge
#362
Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry
286-12-000-574-L04-P
Knowledge
#363
The Changing Face of Clinical Compliance: Regulatory, Technology, and Services
286-12-000-575-L04-P
Knowledge
#365
The Use of Health Technology Assessment (HTA) for Access and Resource Allocation Decision Making:
International Examples
286-12-000-576-L04-P
Knowledge
#366
Data Sources for Monitoring Usage of Drug Products and How to Use These Sources to Support Safety
and REMS Evaluations
286-12-000-577-L04-P
Knowledge
#370
Social Media 2.0: The Power of Online Rare Disease Communities to Connect and Engage ePatients
286-12-000-578-L04-P
Knowledge
#379
Leveraging Drug Development and Advertising/Promotion Regulatory Expertise to Drive a Robust
Target Product Profile Process
286-12-000-579-L04-P
Knowledge
#380
Recent Advances in Adaptive Clinical Trial Designs for Medical Writers
286-12-000-580-L04-P
Knowledge
#381
Sharing Clinical Data: Examples of What to Share and Benefits to Research and Patients
286-12-000-581-L04-P
Knowledge
#384
286-12-000-582-L04-P
Knowledge
#385
Emerging Role of the Patient Voice on Drug Policy in Japan
286-12-000-583-L04-P
Knowledge
#388
The Role of Meta-analyses in Drug Safety: Methodological Considerations
286-12-000-584-L04-P
Knowledge
#389
Benefit Versus Risk of Harm: Assessing Therapeutic Response and Interpreting Benefit/Risk with Patients
286-12-000-585-L04-P
Knowledge
#390
Doping Abuse of Medicines in Sport: The Challenge to Industry and Regulators
286-12-000-586-L04-P
Knowledge
#391
Statistical Comparative Effectiveness Research (CER): Closing the Gaps in the Consideration of Observational Evidence
286-12-000-587-L04-P
Knowledge
THURSDAY, JUNE 28, 2012
Number
Title of Offering
Assigned UAN
Type of Activity
#406
Study Recruitment Challenges, Tailored Medical Information Requests - OH MY! Have You Maximized
All Your Options
286-12-000-526-L04-P
Knowledge
#407
286-12-000-527-L04-P
Application
#418
Medical Writing Competencies and Best Practices in the Global Environment
286-12-000-528-L04-P
Knowledge
#422
Immunogenicity of Therapeutic Peptides: Regulatory Science Implications
286-12-000-529-L04-P
Knowledge
142
NOTES
143
NOTES
144
(As of May 4 2012)
LIST OF EXHIBITORS
Exhibiting As
Addendum available at Exhibior Registration
Booth No.
Page No.
Exhibiting As
Booth No.
Page No.
ABF Pharmaceutical Services GmbH
Booth: 1839
148
Bio-Optronics, Inc.
Booth: 1816
151
Accel Research Sites
Booth: 2508
148
BioPharm Insight
Booth: 1206
152
Accelovance
Booth: 2442
148
bioskin GmbH
Booth: 2406
152
Accovion
Booth: 1936
148
BioSoteria, Inc. see Dohmen Safety
ACM Global Central Lab
Booth: 2327
148
BioStorage Technologies Inc.
Booth: 2344
152
ACR Image Metrix
Booth: 2732
148
Biotec Services International
Booth: 2619
152
Actelion Clinical Research, Inc
Booth: 3313
148
Blue Chip Patient Recruitment
Booth: 3112
152
ActiGraph
Booth: 1639
148
Blue Sky Broadcast
Booth: 2631
152
Acurian, Inc.
Booth: 2807
148
Bracket Global
Booth: 2201
152
Adicon Clinical Laboratory Inc.
Booth: 2641
148
Brand Institute
Booth: 2445
152
Advanced Clinical
Booth: 3014
149
Business & Decision
Booth: 3305
152
Aerotek
Booth: 2901
149
C3i, Inc.
Booth: 2425
152
Afton Scientific Corporation
Booth: 3412
149
Cactus Communications
Booth: 2141
152
Akos Ltd.
Booth: 3207
149
Camargo Pharmaceutical Services
Booth: 3006
153
Alamo Medical Research
Booth: 2341
149
Cape Cod Clinical Research, Inc.
Booth: 2409
153
Allergan, Inc.
Booth: 2524
149
Cardiac Safety Research
Booth: 1100
153
Almac
Booth: 2525
149
Cardio Analytics Ltd.
Booth: 2540
153
Anaheim Clinical Trials
Booth: 2500
149
Cardiocore
Booth: 1300
153
A-PACT (Alliance for Pac-Asia Clinical Trials)
Booth: 1648
149
Catalent Pharma Solutions
Booth: 1539
153
APCER Pharma Solutions, Inc.
Booth: 2736
149
CDISC
Booth: 1525
153
Apothecaries Clinical Research
Booth: 3316
149
Celerion
Booth: 1412
153
Applied Clinical Intelligence, LLC
Booth: 2507
149
Cenduit, LLC
Booth: 3143
153
Applied Clinical Trials
Booth: 1529
149
CenterWatch
Booth: 1736
153
Aptiv Solutions
Booth: 2815
150
Cerner Corporation
Booth: 1448
154
Aris Global
Booth: 2113
150
Cetero Research
Booth: 1307
154
Arriello Group
Booth: 3429
150
Chesapeake IRB
Booth: 1530
154
Asia CRO Alliance
Booth: 1841
150
Children’s Hospital of Orange County
Booth: 1642
154
Aspire IRB
Booth: 2440
150
Chiltern International, Inc.
Booth: 3007
154
Assent Consulting
Booth: 2339
150
Cincinnati Children’s Research Foundation
Booth: 2913
154
The Avoca Group
Booth: 3427
150
CIRION Clinical Trial Services
Booth: 2502
154
Axiom Real-Time Metrics Inc.
Booth: 1717
150
Citeline Inc.
Booth: 3408
154
B. McLaughlin Associates, Inc. (BMA)
Booth: 1136
150
CITI Program - University of Miami
Booth: 2345
154
BARC Global Central Laboratory
Booth: 3211
150
ClearTrial, LLC
Booth: 2030
154
BBK Worldwide
Booth: 2606
150
ClinAudits LLC
Booth: 1544
155
Beardsworth
Booth: 2051
151
ClinDatrix, Inc.
Booth: 2205
155
Beckloff Associates, Inc.
Booth: 1817
151
ClinForce, Inc.
Booth: 2714
155
Benchmark Research
Booth: 2432
151
Clinical Financial Services
Booth: 2801
155
Bilcare Global Clinical Supplies
Booth: 2730
151
Clinical Ink
Booth: 3104
155
BioClinica
Booth: 2707
151
Clinical Reference Laboratory
Booth: 1540
155
152
BioFortis, Inc.
Booth: 1024
151
Clinical Research Advantage
Booth: 2325
155
Biomedical Research Alliance of New York
Booth: 3425
151
Clinical Research Malaysia
Booth: 1849
155
Biomedical Systems
Booth: 1549
151
Clinical Resource Network, LLC
Booth: 2240
155
BioMedTracker
Booth: 1149
151
The Clinical Resource Network
Booth: 2424
155
145
List of Exhibitors
Exhibiting As
Booth No.
Page No.
Clinical Site Services
Booth: 1829
156
Clinical Trial Media
Booth: 1433
ClinicalConnection, Inc.
Booth No.
Page No.
DIA Patient Advocate Fellowship
Booth: 1513
159
156
DiagnoSearch Life Sciences
Booth: 1813
160
Booth: 2332
156
Dohmen Safety
Booth: 2233
160
clinicalRSVP
Booth: 3310
156
DoubleBridge Technologies, Inc.
Booth: 1537
160
Clinlogix
Booth: 1745
156
Dr. Ebeling & Assoc. GmbH
Booth: 2838
160
ClinStar, LLC
Booth: 1819
156
Drexel University Online
Booth: 3239
160
ClinTec International Ltd.
Booth: 1845
156
Drug Development Consultants, Inc./CoreMed Corp.
Booth: 1942
160
Clinverse – eClinical Commerce Network
Booth: 2416
156
Drug Safety Alliance, Inc.
Booth: 2245
160
Cmed Group
Booth: 3315
156
DS InPharmatics
Booth: 2506
160
CMIC HOLDINGS Co., Ltd.
Booth: 2731
156
DSG, Inc.
Booth: 1301
160
Cognizant
Booth: 3336
156
DUCK FLATS Pharma
Booth: 3012
160
Compass IRB
Booth: 2016
157
Duke Clinical Research Institute
Booth: 1917
161
CompleWare Corporation
Booth: 2539
157
d-Wise Technologies
Booth: 2150
161
Compliance Insight
Booth: 3249
157
DZS Software Solutions/ClinPlus
Booth: 2504
161
Comprehend Clinical
Booth: 2516
157
EAS Consulting Group, LLC
Booth: 1739
161
Comprehensive Clinical Research
Booth: 1140
157
EastHORN Clinical Services in CEE, Ltd.
Booth: 1204
161
Consent Solutions, Inc.
Booth: 3248
157
eClinical Solutions
Booth: 1536
161
Contract Pharma
Booth: 2533
157
ECLINSO
Booth: 2306
161
Conversis
Booth: 3314
157
Ecron Acunova
Booth: 2338
161
Copernicus Group IRB
Booth: 2738
157
EDETEK, Inc.
Booth: 2049
161
CoreLab Partners, Inc.
Booth: 2625
157
Elite Research Network, LLC
Booth: 2718
161
Corporate Translations
Booth: 1838
157
Eliving Pharmaceutical Co.
Booth: 3309
161
Cost Management Incentives, Inc.
Booth: 3045
157
EMB Statistical Solutions, LLC
Booth: 2042
162
Court Square Group, Inc.
Booth: 1025
158
EMC
Booth: 2342
162
Business Suite: BS1
158
endpoint
Booth: 3108
162
Entimo AG
Booth: 1837
162
Booth: 1142
158
ePharmaSolutions
Booth: 1427
162
EPS Corporation
Booth: 3217
162
Ergomed Clinical Research
Booth: 1935
162
ERT
Booth: 2725
162
European Medicines Agency
Booth: 1613
162
EUROTRIALS
Booth: 2942
162
Everest Clinical Research
Booth: 2645
162
Exco InTouch
Booth: 3201
163
ExecuPharm, Inc.
Booth: 1429
163
ExL Pharma
Booth: 2426
163
Experis Clinical Practice
Booth: 1628
163
EXTEDO, Inc.
Booth: 1912
163
Fast4wD Ogilvy
Booth: 3236
163
FDA/CBER
Booth: 1614
163
FDA/CDER
Booth: 1612
163
FDA/OC/ACOMS
Booth: 1517
163
Covance Inc.
CPC Clinical Trial Hospital, Medipolis
Medical Research Institute
CRF Health
Booth: 3306
158
CRI Lifetree
Booth: 2615
158
CROMSOURCE srl
Booth: 1733
158
CROS NT Srl
Booth: 1202
158
CRS – Clinical Research Services
Booth: 1249
158
CSC Life Sciences
Booth: 1749
158
CTI Clinical Trial & Consulting Services
Booth: 2401
158
Cu-Tech, LLC
Booth: 2307
159
Cytel Inc.
Booth: 2638
159
DAC Patient Recruitment Services
Booth: 2604
159
DataForm Software
Booth: 3417
159
Datapharm Australia
Booth: 2402
159
DATATRAK International, Inc.
Booth: 2607
159
Datatrial Limited
Booth: 1939
159
DAVA Oncology, LP
Booth: 3407
159
DaVita Clinical Research
DIA
Exhibiting As
Booth: 1812
Business Suite: BS2
159
FDAnews
Booth: 1107
163
Booth: 1501
159
FIRST Robotics
Booth: 1101
163
146
List of Exhibitors
Exhibiting As
Booth No.
Page No.
Flex Databases
Booth: 3209
164
Foresight Group, LLC
Booth: 3238
164
Formedix Inc
Booth: 2148
164
Forte Reseach Systems, Inc
Booth: 1951
164
Frontage
Booth: 1116
164
Fujitsu Limited
Booth: 1449
164
Fundacion De Investigacion
Booth: 3048
Business Suite: BS6
Exhibiting As
invivodata
Booth No.
Page No.
Booth: 1416
Business Suite: BS5
167
Italian Medicines Agency
Booth: 1615
167
JANIX CRO
Booth: 2617
168
Joule Clinical Staffing Solutions
Booth: 1832
168
Jubilant Clinsys Inc.
Booth: 3424
168
The Judge Group
Booth: 1543
168
164
Kansas Bioscience Authority
Booth: 1019
168
Global Instrumentation LLC
Booth: 1641
164
Kayentis
Booth: 1348
168
Global Language Solutions
Booth: 2108
164
Kelly Scientific Resources
Booth: 1200
168
GlobalCare Clinical Trials, LTD
Booth: 1148
164
Klein Hersh International
Booth: 3213
168
GlobalSubmit, Inc.
Booth: 1203
165
KoNECT
Booth: 1519
168
goBalto, Inc.
Booth: 1114
165
Kramer Translations
Booth: 1748
168
Green Key Resources
Booth: 1743
165
LabConnect, LLC
Booth: 3137
168
Greenphire
Booth: 3125
165
LabCorp Clinical Trials
Booth: 2405
169
Greenway Medical Technologies
Booth: 2503
165
Leadership Directories Inc.
Booth: 1827
169
H&J CRO International, Inc.
Booth: 2633
165
Lernia Training Solutions
Booth: 2944
169
HCRAmerica
Booth: 2744
165
Life Science Leader
Booth: 1109
169
Healthcare Communications Group
Booth: 1413
165
Lilly Clinical Open Innovation
Booth: 3428
169
Heat In A Click
Booth: 1548
165
Lionbridge Life Sciences
Booth: 2436
169
High Point Solutions
Booth: 1033
165
Liquent
Booth: 1124
169
I.D.E.A. Ltd.
Booth: 2050
165
Logos Technologies Inc.
Booth: 2041
169
iCardiac Technologies
Booth: 1526
165
LORENZ Life Sciences Group
Booth: 1924
169
ICON plc
Booth: 2701
166
Lovelace Scientific Resources
Booth: 1112
169
Idem Translations, Inc.
Booth: 2848
166
Lyophilization Technology, Inc.
Booth: 2048
169
IFAPP
Booth: 1848
166
MakroCare
Booth: 1833
170
Illingworth Research
Booth: 1948
166
Malvern Consulting Group, Inc.
Booth: 3348
170
Imperial
Booth: 2600
166
MASIMO
Booth: 3250
170
IMS Health/DecisionView
Booth: 2851
166
Massachusetts College of Pharmacy
and Health Sciences
Booth: 3005
170
Inamed GmbH
Booth: 2501
166
Master Control
Booth: 1441
170
INC Research
Booth: 1901
166
MaxisIT Inc.
Booth: 2417
170
Inclinix, Inc.
Booth: 3245
166
McGuire Research Institute
Booth: 1836
170
Indipharm
Booth: 1635
166
MedDRA MSSO
Booth: 1201
170
INNOPHARMA S.r.L.
Booth: 2630
166
Medical Research Network Ltd.
Booth: 2745
170
Innovative Print & Media Group
Booth: 2850
167
Medicines Evaluation Unit
Booth: 1026
170
Integrated Clinical Systems, Inc.
Booth: 1242
167
Medidata Solutions Worldwide
Booth: 3101
170
MedNet Solutions, Inc.
Booth: 3017
171
Medpace Inc.
Booth: 2413
171
MedSource
Booth: 1417
171
MEDTOX Laboratories
Booth: 2439
171
MedTrials
Booth: 1930
171
Merge eClinical
Booth: 2601
171
META Solutions, Inc.
Booth: 2517
171
M-Files Inc.
Booth: 1132
171
IntegReview IRB
Booth: 3102
167
International Dermatology Research, Inc.
Booth: 3215
167
Intertek Cantox
Booth: 1637
167
Intervein Laboratories Pvt. Ltd.
Booth: 3312
167
IntraLinks, Inc.
Booth: 3131
167
Institute for International Research
Booth: 1649
167
Investigator Support Services
Booth: 3008
167
IRB Services
Booth: 1550
167
147
List of Exhibitors
Exhibiting As
Microsoft Corporation
Booth No.
Page No.
Exhibiting As
Booth No.
Page No.
Booth: 1325
Business Suite: BS4
171
Pharmaceuticals and Medical Devices
Agency (PMDA)
Booth: 1616
176
Microsystems
Booth: 1928
171
Pharmalink Consulting Inc.
Booth: 1512
176
Mission3
Booth: 1118
172
PharmaLive.com
Booth: 1533
176
MMG
Booth: 2331
172
PharmaNet/i3
Booth: 2213
Business Suite: BS3
176
MonitorForHire.com
Booth: 1926
172
PharmaSeek
Booth: 1524
176
Montrium, Inc.
Booth: 2844
172
PharmaSys, Inc.
Booth: 2749
176
Moravia
Booth: 1738
172
PharmaVigilant
Booth: 3111
176
Mortara Instrument, Inc.
Booth: 1317
172
PharmaVOICE
Booth: 1308
176
myClin
Booth: 1941
172
Pharm-Olam International Ltd.
Booth: 2538
176
Myoderm Medical
Booth: 1630
172
Philips Respironics
Booth: 2433
176
National Death Index
Booth: 1205
172
Phlexglobal Limited
Booth: 2842
177
New England Institutional Review Board
Booth: 1725
172
Booth: 2512 & 2513
177
New Orleans Center for Clinical Research
Booth: 1516
172
Booth: 1825
177
NextDocs
Booth: 1125
173
POPSICUBE
Booth: 3049
177
Nextrials, Inc.
Booth: 2007
173
PPD
Booth: 1828
177
PRA
Booth: 1113
177
Praxis
Booth: 2531
177
Booth: 1907
177
PrimeVigilance Ltd
Booth: 1931
177
PRL Central Laboratory Services
Booth: 1644
177
Projecis, Inc.
Booth: 1638
178
PROSAR
Booth: 2428
178
Prosoft Clinical
Booth: 3307
178
ProTrials Research, Inc.
Booth: 2612
178
PRUDENTAS LLC
Booth: 2843
178
QPS LLC
Booth: 2948
178
Quality and Compliance Consulting, Inc.
Booth: 2509
178
Quality Associates, Inc.
Booth: 2639
178
Quanticate, Inc.
Booth: 2643
178
Queensland Clinical Trials Network
Booth: 2301
178
Quest Diagnostics Clinical Trials
Booth: 1518
179
Quintiles
Booth: 1401
179
QUMAS
Booth: 1143
179
PHT Corporation
PleaseTech Ltd.
Norwich Clinical Services
Booth: 2317
173
Nova Language Services Ltd.
Booth: 3142
173
Novella Clinical
Booth: 2001
173
November Research Group
Booth: 1532
173
Novotech
Booth: 2038
173
nSpire Health, Inc.
Booth: 1729
173
Ocasa Logistics Solutions
Booth: 1737
173
Octagon Research Solutions, Inc.
Booth: 3225
173
OMERACT
Booth: 1102
174
OmniComm Systems, Inc.
Booth: 3301
174
Online Business Applications
Booth: 2741
174
OpenClinica
Booth: 2012
174
OpenQ, Inc.
Booth: 2740
174
Optum
Booth: 3325
174
Oracle Corporation
Booth: 2825
174
Orlando Clinical Research Center
Booth: 1527
174
Palm Beach CRO
Booth: 1425
174
Paragon International, Inc.
Booth: 2106
174
Paragon Solutions
Booth: 1437
175
Booth: 2224
175
Patient Recruiters International, Inc.
Booth: 2304
175
The Patient Recruiting Agency
Booth: 1944
175
PCM TRIALS
Booth: 2632
175
PDR Network, LLC
Booth: 2207
175
Pediatric Pharmacokinetic Consortium
Booth: 2343
175
Penn Pharma
Booth: 1439
175
Booth: 2125
175
Pharmaceutical Executive
Booth: 1531
175
148
Quorum Review IRB
Booth: 1624
179
Randstad Pharma
Booth: 1207
179
Real Staffing Group
Booth: 1431
179
Reed Technology
Booth: 2751
179
REGISTRAT-MAPI
Booth: 2441
179
Regxia Inc.
Booth: 1545
179
Research Across America
Booth: 2616
179
ResearchPoint Global
Booth: 1943
179
ReSolution Latin America
Booth: 2444
180
Rho, Inc.
Booth: 3100
180
List of Exhibitors
Exhibiting As
Booth No.
Page No.
RPS, Inc.
Booth: 2225
180
RSD, Inc.
Booth: 1741
Exhibiting As
Booth No.
Page No.
TecHorizon S.r.l.
Booth: 1731
184
180
TFDA/Center for Drug Evaluation, Taiwan
Booth: 1618
184
Booth: 2845
180
Theorem Clinical Research
Booth: 3144
184
RWD, A Division of GP Strategies
Booth: 1013
180
Therapak Corporation
Booth: 2430
184
Rx Trials Inc.
Booth: 1632
180
Therapeutics Inc.
Booth: 1208
184
RxLogix Corporation
Booth: 1312
180
TheraSim
Booth: 3148
184
SAGE
Booth: 1826
180
Thomson Reuters
Booth: 3001
184
SAS Institute Inc.
Booth: 1625
180
ThreeWire, Inc.
Booth: 3237
184
Scarritt Group, Inc.
Booth: 3013
180
TIBCO Software
Booth: 1015
185
Schlafender Hase GmbH
Booth: 1938
180
TKL Research, Inc.
Booth: 1217
185
Schulman Associates IRB
Booth: 3000
181
Total Root Concepts, Inc.
Booth: 2337
185
SDL
Booth: 1443
181
TransPerfect
Booth: 2715
185
Sentrx
Booth: 1343
181
Trifecta Multimedical
Booth: 2025
185
SGS
Booth: 1313
181
Trio Clinical Resourcing,
an Aptiv Solutions company
Booth: 2915
185
Sharp Corporation
Booth: 2303
181
TTC, llc
Booth: 2300
185
Sino-American Pharmaceutical
Professionals Association (SAPA)
Booth: 1104
181
UBC
Booth: 2101
185
Sitrof Technologies, Inc.
Booth: 3231
181
University of Iowa Pharmaceuticals
Booth: 3015
185
Small Planet Meetings
Booth: 2637
181
University of the Sciences
Booth: 1248
185
SNBL Clinical Pharmacology Center
Booth: 1144
181
the Uppsala Monitoring Centre
Booth: 2907
186
SNM Clinical Trials Network
Booth: 2849
181
Valesta Clinical Research
Booth: 1319
186
Soltex Consulting LLP
Booth: 3114
182
Veeva Systems, Inc.
Booth: 1445
186
Sonic Clinical Trials
Booth: 1844
182
Verified Clinical Trials
Booth: 1712
186
Southern Star Research
Booth: 1818
182
Veristat, Inc.
Booth: 2739
186
Sparta Systems
Booth: 1037
182
Virtify, Inc.
Booth: 1842
186
Spaulding Clinical Research
Booth: 3117
182
Virtual Clinical Solutions
Booth: 2400
186
Spectra Clinical Research
Booth: 2533
182
VirtualScopics
Booth: 3116
186
SpringFire Lab Network
Booth: 1349
182
Vitalograph
Booth: 2518
186
Statistics and Data Corporation (SDC)
Booth: 2005
182
Wake Research Associates
Booth: 2949
186
Sterling Institutional Review Board
Booth: 2414
182
WCCT Global
Booth: 1727
187
Stiris Research Inc.
Booth: 2032
182
WCI Consulting Limited
Booth: 2243
187
Summit Global Health
Booth: 3350
182
WebbWrites, LLC
Booth: 2044
187
Swiftwater Group
Booth: 1716
183
WebWise Learning, Inc.
Booth: 1949
187
Sylogent
Booth: 2102
183
The Weinberg Group
Booth: 3243
187
Symbio, LLC
Booth: 3043
183
Western Institutional Review Board
(WIRB)
Booth: 2107
187
Synchrogenix Information Strategies, Inc.
Booth: 3329
183
Whitsell Innovations, Inc.
Booth: 1740
187
Synowledge Drug Safety and
Regulatory Affairs Services
Booth: 2100
183
Wingspan Technology Inc.
Booth: 1128
187
Synteract
Booth: 1925
183
Wipro Technologies
Booth: 2900
187
TAKE Solutions
Booth: 2239
183
World Courier, Inc.
Booth: 1213
187
Target Health Inc.
Booth: 2542
183
Worldwide Clinical Trials
Booth: 1913
187
Tarius A/S
Booth: 1636
183
X Factor Advertising
Booth: 2313
188
Tata Consultancy Services
Booth: 1713
183
Xerimis Inc.
Booth: 1916
188
Technical Language Services, Inc.
Booth: 2412
184
Y-Prime LLC
Booth: 1138
188
Technical Resources International, Inc.
Booth: 2340
184
Zinc Ahead, Inc.
Booth: 3149
188
149
(As of May 4 2012)
EXHIBITOR DIRECTORY
ABF Pharmaceutical Services
GmbH
Addendum available at Exhibior Registration
Booth: 1839
ACR Image Metrix
Booth: 2732
Phone: +43-676-844-0338-01
Contact: Donald Rosen
Email: [email protected]
Website: www.acr-imagemetrix.net/
Phone: 888-817-0817
Contact: Elisabeth Lackner
ACR Image Metrix, an imaging contract research organization (iCRO), is a
for-profit subsidiary improving the efficiency of pharmaceutical and medical
device development by using imaging technologies, proven imaging science
and expert radiologists. We provide accurate, consistent, timely and quality data. Our services include scientific consultation, site qualification and
training, image management, analysis and interpretation—all performed in a
tightly controlled regulatory environment.
Website: www.abf-pharma.com
ABF specializes in Central Lab Services and IMP handling. Services range
from importing and exporting IMP, label text compliancy, labeling and QP
services, 24/7 warehousing to temperature controlled transports. Central lab
services range from biological specimen management, storage, analytical
services to kit assembling. We specialize in delivering individualized services
on demand and upon short notice — to supply all trial sites (globally) within
the shortest possible time limits.
Accel Research Sites
Booth: 2508
Contact: Susan Calandra
Website: www.accelclinical.com/
Phone: 919-342-6512
Booth: 2442
Contact: Garrett Smith
Website: www.accelovance.com
Phone: 240-238-4914
Booth: 1936
Contact: Sonja Riebel
Website: www.accovion.com
Phone: +49-6196 7709-339
Booth: 2327
Contact: Cynthia Smith
Website: www.acmgloballab.com
Phone: 585-429-2312
ActiGraph
Booth: 1639
Website: www.actigraphcorp.com/
Phone: 850-332-7900
Acurian, Inc.
Booth: 2807
Contact: Kirk McPoyle
Website: www.acurian.com
Phone: 215-323-9000
Acurian is a global leader of clinical trial patient enrollment & retention
solutions in the life sciences industry. We increase enrollment performance
of sites; we identify, contact, prescreen & refer people in the local area but
unknown to a research site. As a result, sponsors complete enrollment without adding sites, time or CRO change orders.
ACCOVION is a full-service CRO offering premium services for project management, clinical operations including monitoring, safety, data management,
biostatistics, statistical programming, medical writing, and electronic publishing. We serve Pharma, Biotech and Medical Device industries in all types of
projects. Our experts operate internationally.
ACM Global Central Lab
Phone: 856-773-4300
ActiGraph is an industry leading provider of actigraphy based patient monitoring solutions for the global research community. ActiGraph noninvasive
monitoring devices and software deliver objective, continuous physical activity and sleep/wake data to the clinical research team, providing quantifiable
insight into the real world behavior of study participants. With customers in
more than 65 countries, ActiGraph products are the most widely used and
extensively validated devices of their kind.
Accelovance is an award-winning, forward-thinking clinical services provider
who implements patient-centric study solutions. We accelerate enrollment
rates, ensure critical timelines are met and delivery quality data. Fixed price
budgets, guarantees and shared risk relationships are examples of our vested
interest. How can flexible CRO services, six wholly-owned dedicated research
centers, patient recruitment/retention solutions and clinical call center services best support your next study?
Accovion
Booth: 3313
Contact: Patricia Stapleford
Website: www.actelion.com
Actelion is a biopharmaceutical company with four products on the market.
We are proud to have one of the richest product pipelines among pharmaceutical companies of comparable size. Our team of 2,500 committed
professionals around the world is passionate about transforming innovation
into novel medicines that treat diseases with significant unmet medical need.
We will continue to invest in innovation to create lasting value for all, patients
and shareholders alike.
Accel Research Sites are industry-leading clinical research sites with the
clinical expertise, therapeutic experience and capabilities to successfully fulfill
clinical trials in a wide range of therapeutic indications. We pride ourselves
on delivering high quality work to our customers, which include major
Pharmaceutical, Biotechnology, and Clinical Research Organizations. We
conduct Phase I, In-Hospital, Vaccine and Outpatient Phase II-IV trials.
Accelovance
Actelion Clinical Research, Inc
Adicon Clinical Laboratory Inc.
Booth: 2641
Contact: Freyja Cheng
Website: www.adicon.com.cn
Phone: +86-215-429-8073
ADICON Clinical Trial Center, a leading full-service central lab for clinical trials
in China, conducts activities to support new pharmaceutical developments
including clinical trials and CRO (contract research organization) business.
The company’s comprehensive support for clinical trials contributes to realizing rapid and high quality pharmaceutical development.
ACM Global Central Lab is an expanding force in laboratory testing. Our mission is to deliver the highest quality laboratory science and clinical research
services to ultimately provide better treatments that enrich peoples’ lives.
We understand our role in building precision into every step of the process
to keep your clinical trial on schedule. We have a flexible approach to each
study and offer a broad menu of services. Flexible in our Approach, Precise in
our Delivery.
150
Exhibitor Directory
Advanced Clinical
Booth: 3014
Anaheim Clinical Trials
Booth: 2500
Contact: Julie Heneghan
Website: www.advancedclinical.com
Phone: 847-267-1176
Contact: Sarah Park
Website: www.act-trials.com
Phone: 714-774-7777
Advanced Clinical is a full-service CRO with flexible FSP and talent management solutions that works in all areas of clinical development including
preclinical development, translational medicine, and Phases 1-4. Our flexible
solutions are offered through multiple outsourcing models designed meet
each specific client’s needs.
Aerotek
Booth: 2901
Contact: Allyson Curran
Website: www.aerotek.com
Phone: 410-579-3063
ACT, one of the largest, independently-owned clinical research facilities in
the US is recognized as a Research Center of Excellence for the conduct of
Phase I through 4 trials. Our clients include large and small pharmaceutical
and biotechnology companies and CROs. It is an organization committed to
exceeding the needs and expectations of our clients by providing innovative,
professional and superior quality service with integrity and reliability.
A-PACT
(Alliance for Pac-Asia Clinical Trials) Booth: 1648
Aerotek is the #1 U.S. provider of clinical and scientific staffing and provides
the highest level of service through our customized recruiting solutions. By
understanding your industry, our specialized recruiters are aware of hiring
trends and know how to identify the necessary skills for each position.
Afton Scientific Corporation
Booth: 3412
Contact: Katherine Brandt
Website: www.aftonscientific.com
Phone: 434-979-3737
Booth: 3207
Contact: Amanda Coehn
Website: www.akosltd.com
Phone: 919-433-3825
Booth: 2341
Contact: Christy Brown
Phone: 210-253-3426
Website: www.alamomedicalresearch.com
Booth: 2524
Contact: Mary Mikels
Phone: 770-880-3570
E-mail: Email: [email protected]
Almac
Booth: 2736
Contact: Suneet Walia
Website: www.apcerpharma.com
Phone: 609-455-1600
Apothecaries Clinical Research
Booth: 3316
Contact: Brijesh Regal
Website: www.apothecaries.net
Phone: +91-112-450-2550
Applied Clinical Intelligence, LLC
Booth: 2507
Contact: Mark Levine
Website: www.icommittees.com
Phone: 480-270-4257
iCommittees™ is a single, integrated solution which combines over a decade
of expertise in the management of clinical endpoint adjudication and data
monitoring committees with a proprietary, regulatory-compliant technology
platform and a global network of scientific experts. iCommittees™ experience spans multiple therapeutic areas and indications, early phase through
registry studies, and has a footprint in over 50 countries.
Alamo Medical Research (AMR) is dedicated to clinical research in Liver
Disease specializing in Phase I-III Hepatology, Hepatic and Renal Intolerance
trials. AMR occupies a newly expanded outpatient and inpatient Phase 1 facility designed to conduct clinical research with good clinical practices in mind.
Allergan, Inc.
APCER Pharma Solutions, Inc.
Apothecaries has 20 years’ experience delivers superlative compliance levels
& outstanding enrollment rates. Our RISK SHARING DEALS UNDERWRITE
COMPLIANCE. Clinical trials for sponsors based at US, EU, Japan, Australia &
India. Experienced in virtually all therapeutic segments including Pediatric,
Vaccine, Medical Device & Long term follow-up studies. Excellent online project management tools. 100% Site Management Services. The best regulatory
interface in India. Product Registrations in India.
AKOS provides niche, customized Pharmacovigilance, QPPV, Medical
and Scientific services. Since 1991, AKOS has been providing customized Pharmacovigilance services to the clinical industry. AKOS is based in
Harpenden, United Kingdom and Research Triangle Park, NC. To learn more
about AKOS’ services, please go to www.akosltd.com.
Alamo Medical Research
Phone: +82-704-033-3113
APCER PHARMA is a truly global provider of services in Safety, Regulatory
and Medical Affairs. Our team of highly experienced medical and scientific
experts in North America, Europe & Asia gives us deep and wide knowledge
and ensures that we understand and anticipate your needs, offer practical
and actionable advice taking our role from a service provider to a partner. We
take pride in delivering timely & accurate services. We are happy to discuss
pilots and no-cost evaluation of your needs.
Afton prepares cGMP washed empty sterile vials, stoppers and seals (ReadyTo-Fill®) for cGMP aseptic filling operations. Afton Vials™ are used in small
clinical fills and approved commercial injectable drugs. Afton is inspected by
both FDA and MHRA. Worldwide users of Afton Vials™ include small biotechs
and major multinational pharmaceutical companies.
Akos Ltd.
Contact: Sungeun (Grace) Lee
Applied Clinical Trials
Booth: 1529
Contact: Anne Young
Phone: 732-346-3085
Website: www.appliedclinicaltrialsonline.com
Booth: 2525
Contact: Catherine Snyder
Phone: 215-660-8500
Website: www.almacgroup.com
Applied Clinical Trials is the authoritative, peer-reviewed resource and
thought leader for the global community. With a BPA-qualified circulation of
18,250 clinical trial professionals worldwide, Applied Clinical Trials has earned
the status as the industry’s most trusted source for professionals who design,
initiate, manage, conduct and monitor clinical trials.
As a global leader in the management of clinical trial supplies and IXRS®
technology, Almac offers an integrated supply chain management solution
that helps pharmaceutical and biotech companies speed the process of getting new drugs to market by increasing productivity in the management of
sites, patients, and clinical supplies.
151
Exhibitor Directory
Aptiv Solutions
Booth: 2815
The Avoca Group
Booth: 3427
Contact: Laura Owen
Website: www.aptivsolutions.com
Phone: 703-483-6400
Contact: Patty Leuchten
Phone: 609-252-9020
Axiom Real-Time Metrics Inc.
Booth: 1717
Contact: Andrew Schachter
Website: www.axiommetrics.com
Phone: 416-818-9800
Aptiv Solutions is a global biopharmaceutical and medical device development company that provides a portfolio of innovative services including
adaptive trials, translational sciences, regulatory services, pharmacovigilance,
clinical resourcing and the operational support of a global clinical research
organization. Aptiv Solutions is the only CRO to offer design, simulation and
execution of adaptive clinical trials.
Aris Global
Booth: 2113
Contact: Lorra Gosselin
Website: www.arisglobal.com
Phone: 203-588-3000
Primary Focus: Small to Medium Biotech and Pharma --- Axiom delivers
easy-to-use, powerful and cost-effective EDC/Data Management solutions
and services wrapped around your study needs and with cost effective pricing. We deliver a broad range of powerful and intuitive enterprise functionality/modules built around the needs of small to medium biotech, pharma and
CROs. Key features include EDC, DM, randomization, integrated AE/SAE
Safety Database and real-time project and clinical data reporting.
B. McLaughlin Associates, Inc.
(BMA)
ArisGlobal is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced
solutions for maintaining regulatory compliance, workflow automation,
improving operational efficiency and easily sharing information around the
globe.
Arriello Group
Booth: 3429
Contact: Anna Lukyanova
Website: www.arriello.com
Phone: +353-125-44033
Booth: 1841
Contact: Sung Ho Cho
Website: www.asiacroalliance.com
Phone: +82-220-149-500
BMA has been a solution focused, WBENC certified, woman-owned CRO
for over 19 YEARS and provides expertise in clinical trial Data Management,
Clinical Scientist Support, Submission Support, Study Management, including Contract/Budget Negotiation & Informed Consent Review, Auditing,
Cold Chain Management/IP Temperature Monitoring, & Clinical Monitoring.
Contact us today to find out why choosing BMA will provide your team
with CONFIDENCE, TRUST, EXPERTISE, INNOVATION, ACCOUNTABILITY &
DIVERSITY!
Booth: 2440
Website: www.aspire-irb.com
Phone: 619-469-0108
Booth: 2339
Website: www.assentconsulting.com/
Phone: 800-747-0940
Booth: 3211
Contact: Kenneth Kim
Website: www.barclab.com
Phone: 516-719-1052
BBK Worldwide
Booth: 2606
Contact: Jennifer Dinkel
Website: www.bbkworldwide.com
Phone: 617-630-5570
BBK Worldwide is globally renowned for accelerating time to market for
new and improved medicines and treatments by using innovative strategies,
programs, and technologies to streamline the clinical trial enrollment process.
BBK Worldwide has evolved into the internationally recognized leader in
patient recruitment. BBK continues to reshape its industry by combining its
visionary perspective with three decades of experience enrolling thousands
of clinical studies in more than 70 countries.
Aspire IRB, (San Diego, CA) provides independent review board services for
all phases of clinical research. Aspire’s ASAP web portal provides 24/7 access
to study documents. Aspire emphasizes flexibility, efficiency and a commitment to personalized customer service. Aspire is fully AAHRPP accredited
and is proudly WBENC and MBE certified.
Assent Consulting
BARC Global Central Laboratory
BARC Global Central Laboratory was founded over 25 years ago with the
mission to provide services that meet the highest quality of standards, at
highly competitive prices. With laboratories in the Americas, Europe, South
Africa, Australia, China, Japan, and Singapore, BARC’s global reach can meet
all phase I-IV study needs from routine to esoteric testing. We pride ourselves
in the development of strong sponsor relationships by offering consistency,
accuracy, and exceptional project management.
The Asia CRO Alliance aims to provide clinical trials support to small and
medium-sized pharma, biotech, medical device companies as well as multinational CROs. This innovative partnership was created to meet the demand
for more options for conducting Asian clinical trials. Through its strong
presence in Asia, the Asia CRO Alliance believes that it can help serve the
demand by providing flexibility in its services and local expertise while working closely with sponsors and multinational CROs.
Aspire IRB
Phone: 610-430-1847
Contact: Kristen Molina
Website: www.bmclaughlin.com
Arriello is a global provider of regulatory, pharmacovigilance, translations and
labelling services. We pride ourselves on our honesty and integrity and ability
to use the best resources for every project.
Asia CRO Alliance
Booth: 1136
Assent Consulting delivers highly qualified consultants, regular full-time
employees and project teams to companies in the pharmaceutical, biotechnology and medical device industries. Assent’s area of expertise: SAS
Programming, Biostatistics, Clinical Research, Drug Safety, Clinical Data
Management, Medical Review, CDISC Consultancy, Medical Writing, Medical
Information, Clinical Operations, Regulatory Affairs, QA & Compliance. We
have two offices located at Solana Beach, CA and Cupertino, CA.
152
Exhibitor Directory
Beardsworth
Booth: 2051
BioFortis, Inc.
Booth: 1024
Contact: Dan Diaz
Website: www.beardsworth.com
Phone: 908-788-1729
Contact: Steve Chen
Website: www.biofortis.com
Phone: 443-276-2464
BioFortis is a software company that provides enterprise data integration
and data management solutions for clinical and translational researchers
across pharmaceutical, academia, non-profit, and government segments. Our
unique data management and graphical ad hoc querying products are used
by clients to manage patient registries, clinical trials, biobanks, and other
translational research projects in collaborative environments.
Beardsworth is a full-service, niche CRO specializing in complex/rescue
trials. We provide clients with straight talk, strong management & solid
metrics for accurate, trusted study results. Our Investigator Express and
Site Ambassador Program ensure fast start-up, patient recruitment, and
retention for overall cost effectiveness. Stop by, meet our team and learn
how Beardsworth’s 25 years of experience & expertise will take your project
further along the road to success.
Beckloff Associates, Inc.
Biomedical Research Alliance of
New York
Booth: 1817
Contact: Carmela Houston-Henry
Website: www.brany.com
Contact: Christopher Kavlick
Phone: 913-451-3955
Website: www.cardinal.com/us/en/beckloff
BRANY’s core objective is to be the nation’s preeminent clinical trials service
provider, offering an array of comprehensive and efficient support services to
organizations conducting research. BRANY’s unique model offers organizations Local/Central IRB, Study Identification, Billing Compliance, Research
Education and Research Compliance services.
Founded in 1976, Beckloff Associates, Inc. assists companies with worldwide
development of pharmaceutical, biotechnology, and medical device products
through regulatory and product development planning, regulatory authority interaction, regulatory documentation preparation, regulatory publishing
(eCTD or paper), and compliance programs.
Benchmark Research
Booth: 2432
Contact: Andrew Kimball
Phone: 469-854-0294
Website: www.benchmarkresearch.net
Booth: 2730
Contact: Sandy Richwalski
Website: www.bilcaregcs.com
Phone: 800-310-4445
Bilcare IXR provides a sophisticated method of optimizing & managing clinical trials through predictive resupply algorithms, two-way data integration &
real-time study data. Bilcare ensures data integrity, accelerated site initiations
& real-time patient enrollment data. With our superior project management,
Bilcare supplies all levels of service from product inception to commercialization. Bilcare IXR is fully customizable to ensure that all of your trial needs are
met without interruption.
BioClinica
Booth: 2707
Contact: Kimberly Salgueiro
Website: www.bioclinica.com
Phone: 888-392-7456
Biomedical Systems
Booth: 1549
Contact: Traci Cardenas
Website: www.biomedsys.com/
Phone: 314-576-6800
Biomedical Systems is a global provider of centralized diagnostic services
for clinical trials for Cardiac Safety & Efficacy, Pulmonary Function, Imaging,
Neurophysiology, Digital Pathology and ePRO Services. We offer a full suite
of pharmaceutical consulting services including Protocol Development,
Medical Writing and Statistical Analysis. With offices in North America,
Europe and Asia, Biomedical Systems works with over 14,000 clinical sites in
95 countries around the world.
Benchmark Research is a network of multi-therapeutic research sites. With
locations in California, Louisiana and Texas, we pride ourselves on being an
industry leader and strategic partner for our clients. Our philosophy is that
quality is paramount; integrity, professionalism, dedication, and old-fashioned
hard work are imperative to managing successful clinical trials.
Bilcare Global Clinical Supplies
Booth: 3425
Phone: 516-470-6979
BioMedTracker
Booth: 1149
Contact: Michael Hay
Website: www.biomedtracker.com
Phone: 858-200-2341
BioMedTracker identifies investment opportunities in the biotech and
pharmaceutical industry by assessing the relative strength of companies’
clinical drug pipelines and by highlighting potential future catalysts that
could impact those pipelines. The BioMedTracker team looks at clinical trial
data and the regulatory history of each drug to assess its overall likelihood of
approval by the FDA.
Bio-Optronics, Inc.
Booth: 1816
Contact: Maria Durkin
Website: www.bio-optronics.com
Phone: 585-272-1960
Bio-Optronics develops, deploys, and operates software products and
custom information technology solutions to help healthcare professionals
manage and optimize workflow, thus enhancing quality, productivity, and
patient and staff satisfaction. Bio-Optronics offers its industry leading CTMS
software, Clinical Conductor, for clinical trial research sites, CROs and sponsor
groups. Clinical Conductor is coupled with unparalleled customer support
and training.
BioClinica a global provider of integrated, technology-enhanced clinical trial
services. We supports pharmaceutical and medical device innovation with
imaging core lab services, internet image transport, electronic data capture,
interactive voice & web response, clinical trial management and clinical supply chain design and optimization solutions.
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Exhibitor Directory
BioPharm Insight
Booth: 1206
Blue Sky Broadcast
Booth: 2631
Contact: Holly Burke
Website: www.biopharminsight.com
Phone: 781-762-9450
Contact: Jim Bohlen
Website: www.blueskybroadcast.com
Phone: 877-925-8375
BioPharm Insight is your definitive guide to the global biopharma community, combining an online business intelligence system of comprehensive
market analytics and key industry contacts with an independent investigative journalism news service. As part of the Financial Times Group, BioPharm
Insight is also an acclaimed independent journalist team with a proven track
record of breaking forward-looking and competitive business intelligence
6-12 months ahead of mainstream press.
bioskin GmbH
Booth: 2406
Contact: Betsy Hughes-Formella, PhD
Website: www.bioskin.de
Phone: +49-406-068-970
Blue Sky Broadcast specializes in delivering virtual meetings and web based
training for life sciences programs. Our state of the art webcasting platforms
and Learning Portals combined with our attentive, hands on project management has made us a respected leader in the industry.
BioSoteria, Inc.
see Dohmen Safety
Booth: 2344
Contact: Kim Ross
Website: www.biostorage.com
Phone: 317-390-1866
Booth: 2619
Contact: Samantha James
Website: www.biotec-uk.com
Phone: +44-165-675-0550
Brand Institute
Booth: 2445
Contact: Joseph Doerfler
Website: www.brandinstitute.com
Phone: 305-374-2500
Business & Decision
Booth: 3305
Contact: Keri Collette
Phone: 508-395-6439
Website: www.businessdecision-lifesciences.com/
Business & Decision is a multi-national consulting and systems integration
company specializing in services and solutions for the Life Sciences Industry.
Our Life Sciences experts apply their industry knowledge, collaborate with
clients and share insights on critical industry issues to deliver value through
business optimization and the use of appropriate technology.
Biotec has built a global reputation as a company with the commitment
to quality and technical excellence required to support your clinical trials
from Phase I to IV and onto commercial supply. Our services include QP and
GMP Consultancy, Clinical Supplies, GMP Temperature Controlled Storage,
Global Logistics, Advanced Therapeutic Medicinal Products (ATMPS) and
Commercial Services. Biotec is relied upon by clients to deliver critical studies
of various sizes, on time and on budget.
Blue Chip Patient Recruitment
Phone: 415-293-1369
Brand Institute is a premier international branding agency that partners
with healthcare, pharmaceutical and consumer companies to develop brand
names. In operation since 1993, Brand Institute offers a comprehensive list
of branding services including brand strategy/architecture, name development, market research, regulatory, and visual identity solutions. With regional
offices strategically located, we offer the highest level of in-house expertise.
BioStorage Technologies is the premier global provider of comprehensive
sample management solutions for the bioscience industry. With an emphasis on quality, compliance, and technology, we offer flexible offsite, onsite
and hybrid sample outsourcing models; helping companies maximize their
research opportunities, minimize risk, and reduce costs.
Biotec Services International
Booth: 2201
Contact: Jen Burstedt
Website: www.bracketglobal.com
Bracket is a specialty services provider dedicated to helping pharmaceutical
sponsors and contract research organizations achieve greater certainty and
accurate outcomes in their clinical trials by seamlessly leveraging science,
technology and operational excellence. Products and services include: -IVRS/
IWRS -ePRO (via smartphone, web, phone) -Rater Training & Certification
-Scale Management -CDR System (computerized cognitive testing)
-Concordant Rater Station -VERIFIED -In-Study Ratings Reliability
Founded in 1992, bioskin® is a unique and valuable partner in dermatology research services. With state-of-the-art facilities at its headquarters
in Hamburg, and its site in the center of Berlin, bioskin® has experience in
innovative study designs, in-house Phase I safety & Proof-of-Concept studies,
and global multi-center Phase II-IV trials.
BioStorage Technologies Inc.
Bracket Global
C3i, Inc.
Booth: 2425
Contact: Dave Hanaman
Website: www.c3i-inc.com
Phone: 973-585-1843
From its integrated operation centers in North America, Europe, India and
China, C3i helps life science companies conduct more efficient global clinical
trials. C3i’s portfolio of end-to-end technology services for EDC, IVRS, CTMS,
ePRO applications includes: end-user training, 24x7 multi-lingual contact
center, hardware provisioning, application hosting.
Booth: 3112
Contact: Mark Bielecki
Phone: 847-275-0928
Website: www.bluechipww.com/healthcare
Blue Chip Patient Recruitment, a division of Blue Chip Marketing Worldwide,
is a global, full-service patient recruitment and retention agency dedicated
to accelerating clinical trial enrollment. For nearly 20 years and 600 trials,
we have been recognized for our scientific approach to clinical trial marketing, our insights and strategies, our innovative tactics and our best in class
creative. We are known for the intelligent and passionate service that we
bring to every study.
Cactus Communications
Booth: 2141
Contact: Gary Groesbeck
Website: www.cactusmed.com
Phone: 267-332-0051
Cactus Communications is celebrating its 10th year in the industry! CACTUS
has offices in the United States, Japan, India, China, and South Korea.
CACTUS undertakes medical writing, publication support, regulatory writing,
scientific editing, literature analysis, transcription, translation, and medical
writing training projects on behalf of pharmaceutical and medical device
clients.
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Exhibitor Directory
Camargo Pharmaceutical Services
Booth: 3006
Catalent Pharma Solutions
Booth: 1539
Contact: Jenna Heithoff
Website: www.camargopharma.com/
Phone: 308-237-5567
Contact: Holly Rackett
Website: www.catalent.com
Phone: 732-537-6200
Camargo Pharmaceutical Services is an end-to-end drug development service provider specializing in the 505(b)(2) approval pathway. Camargo works
with companies to develop comprehensive programs, managing every facet
of the plan from formulating and testing the drug product, to conducting
clinical studies and FDA application submissions. Connect with Camargo on
the President’s blog www.camargoblog.com or visit www.camargopharma.
com for more information.
From drug and biologic development services to delivery technologies to
supply solutions, we are the catalyst for your success. With over 75 years
of experience, we have the deepest expertise, the broadest offerings, and
the most innovative technologies to help you get more molecules to market
faster, enhance product performance and provide superior, reliable manufacturing and packaging results. Catalent. More products. Better treatments.
Reliably supplied.™
Cape Cod Clinical Research, Inc.
Booth: 2409
CDISC
Booth: 1525
Contact: William Baker
Website: www.cccri.com
Phone: 508-790-4800
Contact: Frank Newby
Website: www.cdisc.org
Phone: 610-942-2464
Since 1998, Cape Cod Clinical Research, Inc. (CCCRI) has been providing the
pharmaceutical and biotech industry with regulatory document management service (TrialDOCS), project management, monitoring, GCP auditing,
site assessments and training programs for research personnel. Our client
approach has involved a commitment to understanding and sharing your
clinical development goals, while keeping your budgets in mind. For more
information, please visit www.cccri.com, or email [email protected].
Cardiac Safety Research
Booth: 1100
Contact: Valarie Morrow
Website: www.cardiac-safety.org
Phone: 919-668-8700
CDISC is a 501(c)(3) non-profit organization, with nearly 300 member
organizations from across the clinical research and healthcare arenas. CDISC
catalyzes productive collaboration to develop industry-wide data standards
enabling the harmonization of clinical data and streamlining research processes. The CDISC Vision is to inform patient care and safety through higher
quality medical research.
Booth: 2540
Contact: Kerri Mellor
Website: www.cardioanalytics.com
Phone: +44-175-220-1144
Booth: 1300
Contact: Veronica Palacios
Website: www.cardiocore.com
Phone: 301-214-7600
Phone: 402-476-2811
Cenduit, LLC
Booth: 3143
Contact: Rebecca Galloway
Website: www.cenduit.com
Phone: 919-998-3372
Cenduit is a leading global provider of Interactive Response Technologies
(IRT) and a privately owned joint venture of Quintiles and Fisher Clinical
Services, part of Thermo Fisher Scientific. Cenduit has a global staff of over
200 quality and customer service-driven IRT experts dedicated to optimizing
patient randomization and drug supply management.
Cardio Analytics has been providing high quality Centralised Cardiology
Services for clinical trials Phase I to III for over 18 years. Carrying out 12-Lead
digital ECG (including TQT Studies), 12-Lead and 3-Lead Holter, Telemetry,
Echo and ABP Measurement and Analysis.
Cardiocore
Booth: 1412
Contact: Farzana Azam
Website: www.celerion.com
Celerion is the premier provider of innovative early stage clinical research
solutions. A full spectrum of resources is available for Phase 0 through IIa
proof-of-concept studies. With six locations and over 730 beds, our experience and expertise is applied to provide solutions to pharmaceutical, biotechnology and generic clients.
The Cardiac Safety Research Consortium (CSRC) was launched in 2006
through a MOU with Duke University to support research into the evaluation
of cardiac safety of medical products. CSRC supports research by engaging
stakeholders from industry, academia, and government to share data and
expertise. Outputs of the CSRC include research projects taking advantage
of waveforms released from the FDA ECG warehouse, “Think Tank Incubator”
programs, and consensus white papers.
Cardio Analytics Ltd.
Celerion
CenterWatch
Booth: 1736
Contact: Amy Fontaine
Website: www.centerwatch.com
Phone: 617-948-5172
Founded in 1994, CenterWatch is a trusted source and global destination of
clinical trials information for both professionals and patients. CenterWatch
provides a wide variety of information services including study leads for
investigative sites; business development leads for service providers; career
opportunity resources; clinical trial listings; advertising and promotional
opportunities; and proprietary market research on the global clinical trials
industry. Visit www.centerwatch.com.
Cardiocore is a leading cardiac core lab that delivers superior global services,
expert scientific consulting and state-of-the-art data and information management. With core lab locations near Washington, DC, South San Francisco,
CA, and London, UK, Cardiocore’s global services include Phase I-IV and
Thorough QT trials for Top Ten pharmaceutical organizations, specialty pharmaceutical firms and emerging biotech companies.
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Exhibitor Directory
Cerner Corporation
Booth: 1448
Contact: Caitlin Phillips
Website: www.cerner.com
Phone: 816-201-8705
Cincinnati Children’s Research
Foundation
Cerner, a global leader in healthcare information technology, is solving
healthcare’s many challenges by connecting the right people with the right
information at the right time. With more than 30 years of experience and our
partnerships at more than 9300 client sites worldwide, we are now focusing on improving healthcare by leveraging technology, data and expertise to
improve research – Healthcare improves when Research improves.
Cetero Research
Booth: 1307
Contact: April Johnson
Website: www.cetero.com
Phone: 877-723-8376
Cincinnati Children’s is a pediatric academic medical center and clinical
research test site conducting Phase I-IV (all major therapeutic areas) and
select adult Phase I-IV studies. AAHRPP accredited, it has more than 1900
active IRB approved protocols annually, more than 700 investigators, 300
GCP trained study coordinators and more than 80 years of pediatric research
experience.
Cetero Research is an industry leading contract research organization (CRO)
in early phase research services. With nearly 30 years of experience, Cetero
has conducted more than 20,000 clinical pharmacology studies and has a
proven track record of providing flexible and high quality clinical development services.
Chesapeake IRB
Booth: 1530
Contact: Lauri Carlile
Website: www.chesapeakeirb.com
Phone: 410-884-2900
Phone: 714-516-4341
Located in an ethnically diverse Southern California community with one of
the largest demographics of children in the nation, CHOC Children’s is the
only hospital in Orange County exclusively serving pediatric patients. CHOC
maintains facilities, regulatory and administrative infrastructure in support of
basic, translational and clinical research - with over 300 clinical trials across
a wide range of therapeutic areas, currently integrated into our continuum of
care.
Booth: 3007
Contact: Susan Ojanen
Website: www.chiltern.com/
Phone: 423-968-9533
Booth: 2502
Contact: Guy Veilleux
Website: www.cirion.com/
Phone: 450-682-2231
Citeline Inc.
Booth: 3408
Contact: Irene Fitzgerald
Email: irene.fi[email protected]
Website: www.citeline.com
Phone: 646-957-8919
Citeline provides the world’s most comprehensive R&D intelligence to the
pharmaceutical industry, covering global clinical trial, investigator and drug
intelligence. Our integrated services combine data with unlimited access to
our analysts, to give you real-time information and intelligence on which to
base critical competitive decisions.
Children’s Hospital of Orange CountyBooth: 1642
Chiltern International, Inc.
CIRION Clinical Trial Services
CIRION is a leading Contract Research Laboratory providing R&D services for
Assay Development & Validation and Global Central Laboratory for Global
Clinical and Pre-Clinical studies. The company offers high level scientific
expertise with large molecules (biologics/biosimilars) and biomarkers in
virology, immunology, molecular biology and microbiology. We offer a
complete range of project management and logistical services with a broad
portfolio of safety and esoteric assays.
Chesapeake IRB has been providing central independent IRB services since
1993. Chesapeake IRB earned AAHRPP accreditation in 2004 and was reaccredited a second time in June 2010. Chesapeake IRB offers a 21 CFR Part
11 compliant, electronic IRB platform (CIRBI) which streamlines protocol
submissions and decreases investigator review turnaround times resulting in
faster subject enrollments.
Contact: Cheryl Willis
Website: www.choc.org
Booth: 2913
Contact: Mark Schuller
Phone: 513-636-0314
Website: www.cincinnatichildrens.org/clinical-trials-office
CITI Program - University of Miami
Booth: 2345
Contact: Leeann Hall
Website: www.citiprogram.org
Phone: 305-243-7970
The Collaborative Institutional Training Initiative (CITI) at the University of
Miami offers customized web-based training in Human Subjects Research,
Good Clinical Practice, Information Privacy and Security, Animal Care and
Usage, Biosafety and Biosecurity, Responsible Conduct of Research and
Export Control Regulations.
Chiltern is a leading, full service, global Contract Research Organization with
extensive experience in the management of Phase I-IV clinical trials across a
broad range of therapeutic areas and contract staffing solutions. With nearly
1,300 people located around the world, we are ready to meet the challenges
of clinical trials.
ClearTrial, LLC
Booth: 2030
Contact: Nicole Marino
Website: www.cleartrial.com
Phone: 312-460-3000
ClearTrial is the leading provider of Clinical Trial Operations (CTO) software,
an integrated system for clinical operations planning, forecasting, outsourcing, and project tracking. Visit us in booth #2030.
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Exhibitor Directory
ClinAudits LLC
Booth: 1544
Clinical Reference Laboratory
Booth: 1540
Contact: Cheri Wilczek
Website: www.clinaudits.com
Phone: 973-492-8108
Contact: Debbie Felice
Website: www.crlcorp.com
Phone: 913-693-8901
Clinical Reference Laboratory (CRL Global Services) is a global full service
central laboratory founded on solid scientific expertise and a strong customer
service focus. CRL has been serving the pharmaceutical industry since
1995 and offers a wide range of testing including Chemistry, Hematology,
Urinalysis, Endocrinology, Serology, Biomarkers, DNA,RNA extraction,
Genotyping and Sequencing. Worldwide global services include the USA, EU,
Australia, Japan, South Africa, Singapore, and South America.
Since 1994, ClinAudits has provided QA and regulatory compliance auditing
and consulting services to the pharma, biotech, medical device and biologics
industries; specifically GCP, GMP, and GLP. While specializing in GXP audits,
services extend from pre-clinical to commericalization of pharmaceuticals,
medical devices, biotechnology, biologicals, and gene therapy agents, and Rx
to OTC drugs, both domestically and internationally. ClinAudits can serve as
your virtual QA unit or preferred vendor.
ClinDatrix, Inc.
Booth: 2205
Contact: John Giammona
Website: www.clindatrix.com
Phone: 949-428-6655
Clinical Research Advantage
Booth: 2325
Contact: Casey Orvin
Website: www.crastudies.com/
Phone: 480-305-5702
ClinDatrix is committed to providing world class, full service clinical research
capabilities and expertise to the biotechnology, medical device, and pharmaceutical industries. Partnering with its clients, ClinDatrix uses a personalized
approach to apply knowledge and experience to the goals of managing,
monitoring, collecting, validating, analyzing, reporting, and delivering quality
clinical data with efficiency and accuracy.
Clinical Research Advantage (CRA) has provided experienced research sites
to the pharmaceutical and CRO industry through its partnerships with independent physician investigators in community based settings since 1992. CRA
is the largest Integrated Site Network in the industry with 33 sites in 7 states
having conducted 1800+ studies in diverse therapeutic areas and ages. CRA
places an emphasis on vaccines and has enrolled 10,721 patients across 146
vaccine studies exceeding enrollment by 158%!
ClinForce, Inc.
Booth: 2714
Clinical Research Malaysia
Booth: 1849
Contact: Ben Spradley
Website: www.clinforce.com/clinforce/
Phone: 919-941-0844
Contact: Zuhaida Asra Binti Ahmad
Website: www.crm.gov.my
Phone: +60-326-980-310
ClinForce provides resource solutions through functional outsourcing,
contract staffing, and direct placement services. With over two decades
of experience, ClinForce is trusted by its clients to identify skilled industry
professionals to help get their products to market faster, and/or complete
contracted projects on time and within budget.
Clinical Financial Services
Clinical Research Malaysia (CRM) is a non-profit Government Trial
Management Network providing access to all clinical trial sites of the Ministry
of Health, Malaysia. CRM is a project of the National Key Economic Areas and
is responsible to develop the national contract research industry.
Booth: 2801
Contact: Kevin Williams
Phone: 888-650-1860
Email: cmurray@clinicalfinancialservices.com
Website: www.clinicalfinancialservices.com
Booth: 3104
Contact: Chris Ramm
Website: www.clinicalink.com
Phone: 336-714-7402
Booth: 2240
Contact: Nicki Norris
Website: www.clinicalresource.net
Phone: 847-215-0437
At Clinical Resource Network, LLC, we make clinical trials “patient-centric”
by bringing the clinical study to patients wherever they live, work or play. We
have been deploying our international network of in-home nurses since 2003
to increase patient enrollment and retention. Perfecting how we conduct
mobile clinical trials is our sole focus. Our highly experienced teams with
diverse backgrounds allow us to execute well. As a result, we deliver evaluable results on time and on budget.
Clinical Financial Services (CFS) is a specialty provider focused on the business and financial management activities for clinical trials. The company
offers a unique blend of contract, regulatory, and investigator grant payment
management services which operate in unison to accelerate cycle times,
manage compliance and risk, and stimulate investigator relationships. The
company provides focused expertise, innovative processes, and integrated
technology ensuring high quality service solutions.
Clinical Ink
Clinical Resource Network, LLC
The Clinical Resource Network
Booth: 2424
Contact: David Iannucci
Website: www.spgcrn.com/
Phone: 919-863-4110
CRN is an innovative and dynamic clinical contractor and project resourcing provider. We support Sponsors/CROs with Clinical Professionals, Data
Management, SAS, Biostatistics, Pharmacovigilance, and Project Teams. Our
solutions provide significant cost savings with an emphasis on quality and
service delivery. If you are seeking clinical/data professionals or rewarding
opportunities CRN sets the standard.
Our proprietary software, SureSource™, is the market’s first true Electronic
Source Record (ESR). Unlike EDC systems, which capture only case report
form data, SureSource™ offers tablet based electronic source documents.
SureSource will dramatically reduce monitoring and data query resolution
costs - while lowering compliance risks.
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Exhibitor Directory
Clinical Site Services
Booth: 1829
ClinTec International Ltd.
Booth: 1845
Contact: Charlie Speno
Website: www.clinicalsiteservices.com
Phone: 443-308-5804
Website: www.clintec.com
Phone: 44-141-226-1120
ClinTec International is a Global CRO with a presence in over 40 countries
worldwide. ClinTec has been providing high quality, clinical research support
to the pharmaceutical, biotechnology and medical device industry since 1997.
ClinTec has the capability to conduct global clinical trials as well as provide
support to local projects.
Clinical Site Services is an enrollment performance company. We increase
enrollment and retention for pharma, CROs and investigative sites through
our site-focused approach and adaptive enrollment process. Our global
patient enrollment services provide for seamless planning, execution and
reporting, in the U.S. and in more than 40 countries.
Clinical Trial Media
Booth: 1433
Contact: Veronica Berk
Website: www.clinicaltrialmedia.com
Phone: 516-470-0720
Clinverse – eClinical Commerce
Network
Contact: Gary Abrahams
Website: www.clinverse.com
Clinical Trial Media is a global patient recruitment and retention company
specializing in outreach, call center, tracking and support services to successfully complete enrollment on time and under budget. CTM has randomized
study patients for thousands of clinical research studies across a wide variety
of therapeutic areas since 1995.
ClinicalConnection, Inc.
Booth: 2332
Contact: Leslie Eisenberg
Website: www.ClinicalConnection.com
Phone: 800-887-0639 Ext. 906
Booth: 3310
Contact: Darran Boyer
Phone: 954-727-5785 Ext. 701
Clinlogix
Booth: 1745
Contact: JeanMarie Markham
Website: www.clinlogix.com
Phone: 215-855-9054
Booth: 1819
Contact: Erin King
Website: www.clinstar.com
Phone: 919-354-3573
Cmed Group
Booth: 3315
Contact: Anna Forster
Website: www.cmedgroup.com
Phone: 908-795-2006
Cmed Group is an innovative clinical trials services and advanced software
provider which includes two divisions: Cmed Clinical Services, a full-service
CRO specialized in the design and delivery of pre-phase III traditional and
innovative clinical studies, and Cmed Technology, an eClinical technology
provider. Central to our business is Timaeus, a cloud-based eClinical platform
that supports Study Design through Reporting.
CMIC HOLDINGS Co., Ltd.
Booth: 2731
Contact: Aya Sasada
Website: www.cmic-holdings.co.jp/e/
Phone: +81-035-745-7033
CMIC - Your Strategic Partner to Lead You into the Asian Market CMIC is a
one-stop gateway to the Asian market supporting pharmaceutical, biotechnology and medical device companies. Our quality services include preclinical and clinical research management, site management, manufacturing,
sales and marketing and consulting services which will be tailored to fit your
unique specifications.
Clinlogix is a full service, multi-therapeutic Clinical Research Service
Organization that provides expert outsourcing on a functional basis - globally. We offer customized, metric-driven, essential services such as Project
management, Monitoring, Data management, Vendor management and
Investigator Site identification and Management. Clinlogix delivers support
with highly experienced and therapeutically aligned professionals on a flexible and scalable global platform.
ClinStar, LLC
Phone: 919-746-7676
Clinverse provides the industry’s first SaaS eCommerce Network for investigator and vendor payments. ClinPay™, automates the entire investigator
payment process from contract execution through site payment, providing transparency for Sponsors, CROs and Investigators: ClinPay prepares
Sponsors for the Physician Payment Sunshine Act. We are integrated with
various e-Clinical systems and our patent-pending technology supports
secure payments in 140 currencies and configures to your workflow needs.
ClinicalConnection offers e-recruitment services to sponsors, CROs and
research sites. With a quarter of a million visitors each month seeking clinical
trial participation via its web portal, http://www.ClinicalConnection.com,
has become the leading non-government web destination for clinical trial
searches and patient referrals. Services include custom clinical trial listings, patient referrals, member database recruitment, and development of
branded recruitment and site support websites.
clinicalRSVP
Booth: 2416
Cognizant
Booth: 3336
Contact: Rohit Wadhwa
Website: www.cognizant.com
Phone: 201-801-0233
Cognizant’s Life Science Practice partners today with 27 of the top 30 global
pharmaceutical/biotech organizations in addition to serving the medical
devices, CRO and life sciences product companies. Cognizant is a leading
provider of IT, consulting, and BPO services, dedicated to helping the world’s
leading companies build stronger businesses.
ClinStar is a Western managed CRO with local operations in Russia, Ukraine,
Belarus and the Baltics. We have 12 years of experience in Phase I-IV clinical
trials across multiple therapeutic areas. Unlike many global CROs, we offer
a substantial local presence across all areas of operations, providing us with
unique local knowledge and personal relationships that benefit your clinical
trial.
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Exhibitor Directory
Compass IRB
Booth: 2016
Contract Pharma
Booth: 2533
Contact: Will Stewart
Website: www.compassirb.com
Phone: 919-593-1357
Contact: Damaris Kope
Website: www.contractpharma.com
Phone: 201-825-2552
Compass IRB is a Central IRB located in Mesa, Arizona with full AAHRPP
accreditation. Compass IRB is dedicated to outstanding customer service and
the protection of human subjects. Compass IRB utilizes a customized online
system “THE ANCHOR™ for online submissions and real time 24/7 tracking of
all IRB documents.
CompleWare Corporation
Contract Pharma is the magazine and website designed specifically for outsourcing decision-makers. From drug discovery to contract manufacturing,
Contract Pharma covers the world of contract services. The annual Contract
Pharma conference will be held September 20 & 21, 2012 at the Hyatt in New
Brunswick, NJ. Stop by our booth for a free subscription and chance to win a
free conference pass.
Booth: 2539
Contact: John Weiler
Phone: 319-626-8888
Website: www.compleware.com
CompleWare Corporation is a full service contract service organization
(CRO) and eClinical provider with a focus on respiratory clinical studies. This
includes full centralized spirometry and electrocardiogram (ECG) capture as
well as home subject data capture and management with a variety of electronic patient reported outcome (ePRO) collection options. CompleWare is
able to increase the speed and accuracy of data capture, control study costs,
and increase subject compliance.
Compliance Insight
Booth: 3249
Contact: Julie Waltz Gerlach,
B.S.N., M.P.H., C.I.P.
Website: www.compliance-insight1.com
Phone: 513-860-3512 Ext. 305
Booth: 2516
Contact: Rick Morrison
Website: www.comprehend.com
Phone: 877-201-3560
Booth: 1140
Contact: Kimberley Myers
Website: www.ccrtrials.com
Phone: 856-753-7335
Booth: 3248
Contact: Susan Brink
Website: www.consentsolutions.com
Phone: 202-497-9633
Copernicus Group IRB
Booth: 2738
CoreLab Partners, Inc.
Booth: 2625
Contact: Daja Herald
Website: www.corelabpartners.com
Phone: 609-936-2600
CoreLab Partners, with offices in North America, Europe and Asia, provides
medical image assessment and cardiac safety services to the bio-pharmaceutical and medical device industries. Driven by best-in-class science, emerging
technologies and service quality, CoreLabs’ is a global leader providing imaging sciences in all major modalities complemented by service offerings in the
conduct of automated ECG, Thorough QT, Holter Monitoring, Ambulatory
Blood Pressure Monitoring & Pulse Wave Analysis.
Corporate Translations
Booth: 1838
Contact: Ted Gawlicki
Website: www.corptransinc.com/
Phone: 860-727-6000
Corporate Translations is an ISO9001:2008 and EN15038 certified and trusted
provider of translation and linguistic validation solutions to the world’s top
life science companies. Our proven methodology and expertise in this highly
regulated industry make us well qualified to translate and format documents
throughout the entire lifecycle of a drug.
Comprehensive Clinical Research is a dedicated Phase I-IV Research Facility
with 22 years of experience conducting trials in multiple therapeutic areas.
A highly experienced team of investigators, clinical research coordinators,
QA experts and regulatory affairs specialists, enable CCR to meet critical
project timelines while maintaining the highest standards of quality.
Consent Solutions, Inc.
Phone: +44-845-450-0805
Website: www.cgirb.com/
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Comprehend Systems creates next-generation clinical visualization and analytics software. Comprehend’s first product, Comprehend Clinical, provides
realtime dashboards, ad-hoc reporting, and drill down across disparate clinical datasources.
Comprehensive Clinical Research
Booth: 3314
Website: www.conversisglobal.com
Contact: Rebecca Sipes
Phone: 888-303-2224 Ext. 151
Compliance Insight specializes in Regulatory and Quality Assurance consulting and training for pharmaceutical, nutraceutical, medical device, chemical,
and bio-technology companies in North America, Europe and Asia.
Comprehend Clinical
Conversis
Cost Management Incentives, Inc.
Booth: 3045
Contact: Lorrie Desorbo
Website: www.cost-management.com
Phone: 203-234-6063
Whether you are a professional seeking employment, or a company seeking
talent, Cost Management Incentives, or “CMI”, is your placement specialist for
the pharmaceutical and biotechnology industries. For 20 years, we have been
dedicated to making both contract and permanent placements nationwide,
working with the industry’s top-leading corporations in the areas of clinical
research, project management, medical writing, data management, regulatory, safety, and more. Visit #3045 to learn more!!
ConsentSolutions, Inc provides e-consent. SecureConsent enables trial candidates to review approved consent documents with embedded education
and handwritten digital signatures. ConsentSolutions provides e-consent
localization and clinical site training. CS offers clinical trial teams a staff with
over 15 years of experience in the areas of online data management and
patient education.
159
Exhibitor Directory
Court Square Group, Inc.
Booth: 1025
CROMSOURCE srl
Contact: Keith Parent, CEO
Website: www.courtsquaregroup.com
Phone: 413-746-0054
Contact: Margherita Mosconi
Phone: +39-0458222811
Website: www.cromsource.com
CSG is a professional consultancy specializing in the needs of FDA regulated
companies, including IT planning, network, security and project management.
CSG has expertise in business process optimization, auditing and quality
(including validation), clinical data services, application development, and
provides secure cloud based hosted and managed systems.
Covance Inc.
CROMSOURCE is an international full service Clinical Research Organization
headquartered in Verona, Italy, that provides a wide range of clinical research
services and staffing solutions to the pharmaceutical, biotechnology, vaccine
and medical device industries and works across all therapeutic areas. Early
phase clinical research is conducted in our modern, hospital-based facility
which also provides access to well-defined patient populations. To learn more
please visit www.cromsource.com.
Business Suite: BS1
Phone: 609-419-2240
Website: www.covance.com
Covance is one of the world’s largest and most comprehensive drug
development services companies with more than 10,000 employees in 60
countries. Through its discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies
develop one-third of all prescription medicines in the market today.
Contact: Robert Phillips
Website: www.cpc-global.jp
We are a 60-bed Phase I Unit; in Japan, committed to quality, safety
and innovation: Quality: ISO15189 Accredited Clinical Laboratory Safety:
ACLS trained staff; hospital design incorporates numerous safety features
Innovation: Phase-I, Bridging, tQT, FIM studies in numerous therapeutic areas;
PD technology including Flow Cytometry, Platelet Aggregation/Function etc;
International capabilities for overseas sponsors.
Booth: 3306
Contact: Heather Bilinski
Website: www.crfhealth.com
Phone: 267-498-2349
Booth: 2615
Contact: Mary Brooks
Website: www.crilifetree.com
Phone: 856-533-5012
Booth: 1202
Contact: Mary Wieder
Website: www.crosnt.com/
Phone: +39-0458202666
CRS – Clinical Research Services
Booth: 1249
Contact: David Surjo
Website: www.crs-group.de
Phone: +49-263-299-2784
CRS delivers Phase I-IV CRO full service or trial options. FIM to PoC with
Thorough QT, Special Patient Groups -hepatic -renal, -post menopausal
and complex endpoint study specialties. CRS Clinical Research Services
means competence in Clinical Development with its Human Pharmacology
Infrastructure of 186 bed in 3 units, GLP-certified Bioanalytics, GMP-certified
Pharmacy, Project Management, Monitoring, Biostatistics, Datamanagement,
Medical Writing and Non-interventional studies.
CRF Health is a global leader in eCOA (eClinical Outcomes Assessments)
solutions for the life sciences industry. eCOA encompasses PRO (Patient
Reported Outcomes), ObsRO (Observer Reported Outcomes) and ClinRO
(Clinician or Rater Reported Outcomes). Through innovative technology, a
thorough understanding of drug development, and mobile computing, CRF
Health is driving the change to higher quality outcomes and more efficient
paper-free clinical trials.
CRI Lifetree
CROS NT Srl
CROS NT is a global CRO specializing in statistical analysis, data management, eCRF, ePRO and Life Science Application Hosting. Founded in 1992,
CROS NT has completed over 800 studies in a wide range of therapeutic
areas for clinical and observational studies with expertise in oncology, respiratory and dermatology. CROS NT’s technology arm, ARITHMOS, offers innovative solutions for clinical trials including a software platform for managing
sales, project management, resources and finance.
CPC Clinical Trial Hospital, Medipolis Booth: 1142
Medical Research Institute
Phone: 81-992-595-243
CRF Health
Booth: 1733
CSC Life Sciences
Booth: 1749
Contact: Fran Interrante
Email: fi[email protected]
Website: www.csc.com
Phone: 610-407-5634
CSC Life Sciences offers products and services to manage the large amounts
of data involved in bringing products to market while meeting global regulatory requirements. Services include enterprise-wide data management;
secure collaborations and document management for Documentum and
SharePoint; Combining domain expertise and innovative technology, CSC is
uniquely positioned to help clients achieve quantifiable business results when
developing new pharmaceutical innovations.
CRI Lifetree is a leader in early stage research with expertise in pain, abuse
liability, psychiatry, neurology and diabetes. CRI Lifetree offers a range of
Phase I-IV services to meet the requirements of complex clinical trials and
conducts inpatient and outpatient trials in Philadelphia, New Jersey and Salt
Lake City.
CTI Clinical Trial & Consulting
Services
Booth: 2401
Phone: 513-598-9290
Contact: Nick Schatzman
Website: www.ctifacts.com
CTI is a full service global CRO/consulting company offering a range of
services which encompass the entire lifecycle of drug development. Services
include regulatory pathway design, clinical trial management, data analysis,
medical writing, CME, training program development, market analysis and
other consulting services. CTI focuses on the specific disease areas of solid
organ transplant, hepatitis, infectious disease, end-stage organ disease and
regenerative medicine.
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Exhibitor Directory
Cu-Tech, LLC
Booth: 2307
DATATRAK International, Inc.
Booth: 2607
Contact: Kathleen Ashenfelter or
Anna Majeranowski
Phone: 973-331-1620
Contact: Lisa Pahl
Website: www.datatrak.net
Phone: 979-393-9025
Website: www.cu-tech.com/
Cu-Tech, LLC is a full-service CRO, celebrating two decades of premier
service to the pharmaceutical industry, specializing in Dermatology clinical
trials management, conduct, and monitoring. Cu-Tech professionals offer a
complete array of services and consultation to the client from the inception
to completion of a project. We maintain an extensive database of the finest
dermatologists in North America and abroad. Our clients can attest to our
personal hands-on approach.
Cytel Inc.
Booth: 2638
Contact: Mike Weitz
Website: www.cytel.com
Phone: 617-661-2011
DATATRAK International is a global technology and services company delivering eClinical solutions and related services for the clinical trials industry.
DATATRAK built its multi-component, comprehensive solution on a single,
unified platform and expanded this concept to include services delivery via
DATATRAK’s Clinical and Consulting Services™ group.
Booth: 2604
Contact: Melynda Geurts
Website: www.DACprs.com
Phone: 469-916-8636
DAC Patient Recruitment Services An Imperial Company With 20 years’
experience in 100 countries and 40 indications, DAC Patient Recruitment
Services develops patient recruitment and retention campaigns for global
clinical trials. Core competencies include strategic site selection, project
management, creative services and world-class training. Call (800) 466-1774
or visit www.DACprs.com.
DataForm Software
Booth: 3417
Contact: Rodney Elliott
Website: www.dataformsoftware.com
Phone: 973-882-8835
Phone: 919-277-0050
DAVA Oncology, LP
Booth: 3407
Contact: Tasha Henry
Website: www.davaonc.com
Phone: 214-360-7473
DaVita Clinical Research
Booth: 1812
Contact: Kevin Goudreau
Business Suite: BS2
Phone: 508-721-9666
Website: www.davitaclinicalresearch.com
DaVita Clinical Research (DCR) advances the knowledge and practice of
kidney care and the research of other complex disease states. DCR helps
biotechnology, pharmaceutical and medical device companies conduct
successful clinical trials. DCR’s Early Clinical Research, Clinical Development
and Central Laboratory have extensive CKD and ESRD experience. Additional
support includes Data Research, Health Economics and Outcome Research,
Advisory Committee Preparation Service and Medical Communications.
DataForm Software develops and delivers R&D Program Management
solutions that fully integrate team management, financial planning, project
management, and analysis and reporting. These solutions measurably reduce
administrative cost, improve resource utilization and expedite development
timelines, thus bringing pharmaceutical products to market faster, helping
people and contributing bottom line benefits.
Datapharm Australia
Booth: 1939
Contact: Julie Wright
Website: www.datatrial.com
Datatrial is an oncology-focused boutique clinical data organization that
provides the reliability of a big company, but the personalized service and
flexibility of a more nimble provider. We design your study with insight,
innovation and expertise, backed by comprehensive bio-statistical and consulting services. With more than a decade of experience and offices in both
Europe and the U.S., we bridge the huge gap between the promise of clinical
outsourcing and the way you want results delivered.
At Cytel, we use science and technology to change how clinical trials are
designed and conducted because it improves success rates. Pioneers in
adaptive designs, all 25 leading biopharmaceutical companies rely on us
when planning and implementing their trials. More at cytel.com
DAC Patient Recruitment Services
Datatrial Limited
DIA
Booth: 1501
Contact: Mike Keller
Website: www.diahome.org
Phone: 215-442-6100
DIA is the global forum for knowledge exchange, fostering innovation to raise
the level of health and well being worldwide.
Booth: 2402
Contact: John Edington
Phone: +61-297-192-800
Website: www.datapharm.com.au
DIA Patient Advocate Fellowship
Booth: 1513
Contact: Donna Mayer
Phone: 215-293-5817
Website: www.diahome.org/en/Flagship-Meetings/DIA2012/MeetingProgram/Patients/Patient-Advocate-Fellowship-Program.aspx
Datapharm Australia, celebrating 25 years, is the most experienced, allAustralian, full service CRO having conducted 100s of studies (Phase I to IV)
in over 35 therapeutic areas. Datapharm provides expertise in clinical trial
design, monitoring, data management, statistical analysis and reporting,
medical writing, pharmacovigilance and auditing.
Patient organizations are key players in DIA’s mission and vision. Through
DIA’s programs, patient representatives have opportunities to develop,
strengthen, and support collaborations with policymakers, industry, academia, and health professionals. DIA is working to ensure that the voice of
the patient is heard globally in every facet of the life cycle management of
pharmaceuticals. More than 20 patient advocates will be available to meet
with you to promote dialogue and share best practices.
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Exhibitor Directory
DiagnoSearch Life Sciences
Booth: 1813
Drug Development Consultants, Inc./
CoreMed Corp.
Contact: Jennifer Gidley
Phone: 267-893-6643
Website: www.diagnosearch.com
Booth: 1942
Phone: 703-566-9181
Contact: Ron Filler
Website: www.coremed.co.jp
DiagnoSearch is a full service CRO headquartered in Mumbai, India offering
clinical operations in India, Mexico, and South Korea. A US office provides
client support. DiagnoSearch has over 16 years of Phase I-IV experience
across a broad therapeutic spectrum, having supported 145+ clinical trials,
passed 160+ CQA audits with 135 professionals across Clinical Operations,
Data Management, Biostatistics, CAP Accredited Central Laboratory,
Pharmacovigilance & Consulting.
DDCI and CoreMed Corp are in a complimentary partnership that offers
global (FDA, EMA, MHLW/PMDA) consulting services to the pharmaceutical and biopharmaceutical industries. Providing guidance on nonclinical and
clinical aspects to meet regulatory requirements, assessing potential development concerns from preclinical studies, conducting clinical trials, and filing
IND/CTD/Orphan Drug/DME applications.
Dohmen Safety
Booth: 2233
Drug Safety Alliance, Inc.
Contact: Les Williams
Website: www.dohmensafety.com
Phone: 510-295-6438
Contact: Catherine Crumpton
Phone: 919-401-8003
Website: www.drugsafetyalliance.com
Dohmen Safety is the premier medical communications call center and
pharmacovigilance service provider to pharmaceutical and medical device
companies, offering global pre- and post-approval services, award-winning
educational programs, and unmatched experience to maximize the benefitrisk profile of your products and protect your patients.
DoubleBridge Technologies, Inc.
Booth: 1537
Contact: Jimmy Chen
Website: www.rosettaectd.com/
Phone: 609-716-9001
Drug Safety Alliance, Inc. is a global leader in safety and risk management
services supporting pharmaceutical, biotech, medical device, consumer
health and animal health organizations. DSA promotes patient safety and
product longevity through innovative approaches to post-marketing and
clinical case processing, adverse event reporting, risk evaluation and mitigation and signal management. DSA is headquartered in Research Triangle
Park, North Carolina.
Established in 1997, DoubleBridge Technologies provides software and IT
services to life sciences industry and regulatory agencies. Trusted by 9 of the
world’s top 20 life sciences companies, our ROSETTA suite of software offers
enterprise-wide, holistic views and management of your company’s regulatory information. Visit www.doublebridge.com/rosetta for details
Dr. Ebeling & Assoc. GmbH
Booth: 2838
Website: www.ebeling-assoc.com
Dr. Ebeling & Assoc. GmbH is a European-based contract service provider
in the field of medical affairs, pharmacovigilance and regulatory (EU vs US)
for drugs, biologics and medical devices. Since 2005, we are providing cost
effective medical and regulatory affairs solutions, if you need an EU-QPPV or
EU Legal Representative - we have the experience to support you!
Booth: 3239
Contact: Kelly Hoffman
Website: www.drexel.com
Phone: 215-571-3905
DS InPharmatics
Booth: 2506
Contact: Jennifer Seibert
Website: www.DSinPharmatics.com
Phone: 215-272-4275
DS InPharmatics, a CMC and Regulatory Affairs consulting firm, combining
in-depth technical knowledge of product development with regulatory strategy and content authoring for all phases of the review and approval process.
CMC HealthChekTM is a comprehensive gap analysis and risk assessment
of the scientific content supporting Module 3 CTD. Whether your needs are
comprehensive or tightly focused, DSI consultants will help keep your drug
development program on track and under budget.
Contact: Dr. Leonardo Ebeling
Phone: +49-40-548007-292
Drexel University Online
Booth: 2245
DSG, Inc.
Booth: 1301
Contact: Jack Minster
Website: www.dsg-us.com
Phone: 484-913-0210
DSG, Inc. celebrates its 20th anniversary of supporting clinical trial data
collection and management with a fully integrated suite of innovative
technology solutions including industry award-winning Electronic Data
Capture with specialized Clinical Data Management services, IWRS, Safety
Reporting, Patient Profiles, Electronic Patient Reported Outcomes, Clinical
Trial Management Systems, on-demand CDISC SAS exporting, and digital ondemand Case Report Form publishing management software.
Drexel is a top-ranked, comprehensive university, recognized as a burgeoning center of innovative academic excellence. Drexel offers 100+ degree
programs online, bringing its recognized faculty and curricula to a worldwide
student body. Drexel’s renowned partnership program offers discounted
tuition to employees of partner organizations, enabling a highly-educated,
expert workforce.
DUCK FLATS Pharma
Booth: 3012
Contact: Pam Lazor
Website: www.dfpharma.com
Phone: 315-689-3407
DUCK FLATS Pharma is an expert consulting and contract firm specializing
in clinical pharmacology, nonclinical development and translational medicine.
Pharmacology/Toxicology/ADME studies and analyses, PK & PK/PD analyses
and POP PK modeling, Statistics, Phase 1/2 clinical pharmacology trials,
including pediatric and oncology studies, regulatory consulting; solid record
of successful White Papers, IND and NDA/CTD submissions.
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Exhibitor Directory
Duke Clinical Research Institute
Booth: 1917
ECLINSO
Booth: 2306
Contact: Suzanne Pfeifer
Website: www.dcri.org/
Phone: 919-668-8700
Contact: George Masoura
Website: www.eclinso.com
Phone: 855-245-0987
The Duke Clinical Research Institute (DCRI) offers the full-service operational
capabilities of a major contract research organization combined with clinical
expertise, academic leadership, and business acumen that translates into
targeted and sound research results. The DCRI… From Thought Leadership to
Clinical Practice.
d-Wise Technologies
Booth: 2150
Contact: Tanyss Mason
Website: www.d-wise.com/
Phone: 919-600-6232
ECLINSO is an innovative provider of Clinical Technology solutions and
support services to enhance the conduct of clinical trials. Its Trialforce™
platform is easy to deploy, accessible and scalable. Using a subscription
based service that saves time and cost in study deployment Trialforce™ delivers Electronic Data Capture and Data Management, Electronic Document
Management, Regulatory Solutions and Services, 24 Hour Support Services
and Professional and Consulting Services.
Ecron Acunova
At d-Wise, we believe the key to lasting success in this changing global
business environment is innovation – the actual application of new ideas to
improve your organization’s efficiency, effectiveness, and overall competitive advantage. Innovation requires moving beyond the data to find creative
answers to problems no one else can solve allowing your organization to
achieve its potential as a leader in today’s economy.
DZS Software Solutions/ClinPlus
Booth: 2504
Contact: Bob Borysko
Website: www.clinplus.com
Phone: 732-764-6969
Ecron Acunova (EA) is an expert CRO with 25 years of track record. EA offers
full-service clinical research including clinical operations, project management, data management, biostatistics, pharmacovigilance, PK/PD services
and central lab to pharma, biotech, medical device, nutrition and diagnostic
companies. EA covers 19 European as well as 9 South Asian & SEA countries.
EA operates each region as a priority market with European HQ in Frankfurt,
Asian HQ in Bangalore, and US HQ at Princeton.
DZS Software Solutions (www.clinplus.com) provides clinical trials software
for data management, analysis, reporting and trial management to Life
Science clients worldwide. DZS solutions improve productivity, maximize the
value of clinical research investments, gain client competitive advantage and
get medicines and products to market faster.
EAS Consulting Group, LLC
Booth: 1739
Contact: Edward A. Steele
Website: www.easconsultinggroup.com
Phone: 703-684-4438
Contact: Leonard Gold
Website: www.easthorn.eu
Phone: 781-205-8145
Booth: 2718
Founded in 2004, Elite Research Network is a group of independently owned
investigator sites which conduct clinical studies in all therapeutic areas and
phases, including Phase I. We have earned a reputation for quick study start
up time lines, high enrollment and providing our clients with quality data. Our
sites utilize central IRBs.
EastHORN Clinical Services in CEE is a full-service CRO that offers high-value
Phases I through IV clinical trial capabilities in Central and Eastern Europe.
EastHORN consistently achieves the last-patient-out milestone within the
proposed budget and schedule. We are the ideal regionally-focused CRO.
Booth: 1536
Phone: 609-720-0888
Contact: Christopher Hoyle
Phone: 843-849-7382
Website: www.eliteresearchnetwork.com
Booth: 1204
Contact: Jodi Levin
Website: www.eclinicalsol.com
Booth: 2049
Contact: Marina Yu
Website: www.edetek.com
Elite Research Network, LLC
Phone: 908-317-2846
eClinical Solutions
EDETEK, Inc.
EDETEK, a proud CDISC Registered Solution Provider, provides innovative
end-to-end data management solutions. Key products and services include
eClinical (EDC, IWRS, Patient Recruiting, Site Management, Study Calendar,
Financial Management), eInformatics (Data Integration, Standardization,
Analysis, Reporting), and eSubmission Solutions. We deliver quality services in every aspect of trial design, conduction, analysis, and regulatory
submission.
EAS Consulting Group, LLC (EAS) is a leading provider of regulatory consulting services to the pharmaceutical and medical device industries. The firm
has over 50 years of experience assisting clients in developing regulatory
strategies, implementing quality assurance programs, filing regulatory submissions and ensuring compliance with FDA regulations. Employing a unique
team of FDA officials and industry experts, EAS offers unparalleled expertise.
EastHORN Clinical Services in CEE, Ltd.
Booth: 2338
Contact: Dorothea Hackstein
Phone: +49-696-680-300
Website: www.ecronacunova.com
Eliving Pharmaceutical Co.
Booth: 3309
Contact: Fiona Zhao
Email: fi[email protected]
Website: www.eliving-pharm.com
Phone: +86-21-3331 5121
Eliving Pharmaceutical Co., Ltd. is a full-service CRO headquartered in
Shenyang, China with offices in Beijing, Shanghai and other 15 cities across
China. Our central laboratory is the first CNAS certified CRO laboratory in
China. Allied with 11 national clinical research hospitals, we have established
Liaoning Clinical Research Center (LCRC). Our 300 quality people have
provided excellent services to more than 100 clients. We want to be your
preferred partner in China!
eClinical Solutions is a clinical systems technology organization that provides
a best-in-breed data repository (eGrex) which enables life sciences organizations to optimize the aggregation, standardization and analysis of their
clinical data throughout the clinical development lifecycle through a blend
of innovative technologies and consultation. In addition, we offer reporting,
mapping and training services, as well as EDC services for the benefit of
sponsors and CROs.
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Exhibitor Directory
Booth: 2042
EPS Corporation
Booth: 3217
Contact: Brenda Bishop
Website: www.EMBStats.com
Phone: 816-522-6340
Contact: Askold Kozbur
Website: www.eps.co.jp/en
Phone: 847-517-1005
EMB is a CRO specializing in the Data Management and Statistical Analysis/
Reporting of clinical research data. EMB was formed in 2000 with a dedicated team of senior level associates each with over 15 years of industry
experience and a proven track record of success. EMB is associate owned, has
had ZERO turnover, and is “Powered by Experience”.
EPS Corporation is a full-service CRO with Headquarters in Japan, 22 offices
in 7 countries, and operations in Japan, China, and Southeast Asia. EPS
provides R&D support to pharmaceutical, biotech, medical device companies,
and CROs. EPS also provides SMO, IT, Professional Support Call Center, and
Contract Sales Organization services in Asia Pacific.
EMC
Booth: 2342
Ergomed Clinical Research
Booth: 1935
Contact: Lauren McDonnell
Website: www.emc.com
Phone: 866-438-3622
Contact: Rania Al-Shami
Website: www.ergomed-cro.com
Phone: +971-4-374-9783
EMC Corporation is a global leader in enabling businesses and service providers to transform their operations and deliver IT as a service. Fundamental
to this transformation is cloud computing. Through innovative products and
services, EMC accelerates the journey to cloud computing, helping IT departments to store, manage, protect and analyze their most valuable asset —
information — in a more agile, trusted and cost-efficient way.
endpoint
Booth: 3108
Contact: Ryan Keane
Website: www.endpointclinical.com
Phone: 415-531-5917
ERGOMED is a dynamic and successful transatlantic clinical development
and research company, with operations in over 20 European countries, North
America and MENA. The Company has planned, managed, monitored, and
reported clinical trials with a range of technologies that include small molecule drugs, monoclonal antibodies and other targeted agents, cancer vaccines and immunotherapy, radioactive agents, and photodynamic therapies.
endpoint is an innovative company dedicated to the development of the
leading technology platform to support the life sciences industry. Our
founding team has been developing Integrated Response Technology (IRT)
systems for clinical trials since 1998. We have excelled at the critical aspect
of marrying the latest technology to unsurpassed client service in order to
continuously exceed client expectations.
ERT
Booth: 2725
Contact: Sheryl Walder
Website: www.ert.com
Phone: 215-972-0420
ERT is the leading provider of cardiac safety, respiratory & multi-mode ePRO
solutions to the global biopharm industry. ERT harnesses internet & telecom
technology & services to streamline the clinical trials process by enabling its
customers to automate the collection, analysis & distribution of data in all
phases of clinical development.
Entimo AG
Booth: 1837
European Medicines Agency
Booth: 1613
Contact: Dimitri Kutsenko
Website: www.entimo.com
Phone: +49-30-520024-100
Contact: Beatrice Fayl
Website: www.ema.europa.eu
Phone: +44-207-418-8426
Entimo is a product oriented life sciences and regulatory informatics
company. It delivers high-quality IT products, custom solutions and services
which shorten the drug research and development processes of the pharmaceutical industry. Entimo uses current IT standards, methods and tools to
create and deliver regulatory compliant and cost saving products as well as
professional services that cover the customers’ needs in the pre-clinical and
clinical development areas.
ePharmaSolutions
The European Medicines Agency is the European Union body responsible for
coordinating the existing scientific resources put at its disposal by member
states for the evaluation, supervision, and pharmacovigilance of medicinal
products.
Booth: 1427
EUROTRIALS
Booth: 2942
Contact: Alexandre Gamito
Phone: +35-121-382-5440-457
Website: www.eurotrials.com
Eurotrials is a private independent company founded in 1995 in Lisbon,
Portugal, providing CRO services in R&D and general consulting in the Health
sector in Europe and Latin America. Eurotrials is in Brazil since 2001 and
opened offices in Argentina and Chile in 2011. We are small enough to care
and big enough to deliver!
Contact: Lance Converse
Phone: 610-832-2100
Website: www.epharmasolutions.com
ePharmaSolutions is a global service provider that uses portal-based technology to accelerate and improve site selection, study launch, study management and patient enrollment. Our platform has been created to enable
sponsors, CROs and sites to streamline and systemize processes while saving
costs and expediting timelines. ePS’ single-sign-on portal solutions have
been used to activate and support more than 265,000 clinical researchers in
120 countries for the top 30 pharmaceutical companies.
Everest Clinical Research
Booth: 2645
Contact: Irene Zhang
Website: www.ecrscorp.com
Phone: 905-752-5201
Everest Clinical Research Services Inc. is a contract research organization
providing clinical research services to pharmaceutical, biotechnology, and
medical devices companies. We serve some of the best-known companies
worldwide, and work with many of the most advanced drugs and medical
devices in development today. Welcome to our corporate website www.
ecrscorp.com.
164
Exhibitor Directory
Exco InTouch
Booth: 3201
Fast4wD Ogilvy
Booth: 3236
Contact: Chris Watson
Website: www.excointouch.com
Phone: +44-127-970-9040
Contact: Marie Emms
Website: www.fast4wdogilvy.com
Phone: 212-237-4000
Exco InTouch is the leading provider of regulatory compliant interactive
mobile patient engagement solutions that support Clinical, Late Phase
and mHealth programs. Exco InTouch solutions provide simple, quick and
non-intrusive channels of communication that enable sponsors, CROs, sites
and patient recruitment agencies, find the right patients; motivate them to
maintain full compliance and facilitate the collection of quality patient data,
thus ensuring a better overall patient experience.
ExecuPharm, Inc.
Booth: 1429
Contact: Penny Johnson
Website: www.execupharm.com/
Phone: 610-272-8771
Fast4wD Ogilvy is your passport to the world of patient recruitment and
retention. We offer tailored, global programs to support the participant’s
journey through a clinical trial; from initial awareness, through being informed
and finally engaged and adherent in the study, with insights and solutions
every step of the way.
Booth: 2426
Contact: Michael Goldberg
Website: www.exlpharma.com
Phone: 212-400-6244
Booth: 1628
Contact: Jim Balcom
Website: www.experis.us/clinical
Phone: 269-553-5130
Booth: 1912
Contact: Ellie Stone
Website: www.extedo.com
Phone: 877-378-2647
FDA/CDER
Booth: 1612
Contact: Michael Ledley
Website: www.fda.gov
Phone: 301-796-3107
FDA/OC/ACOMS
Booth: 1517
Contact: Doreen Brandes
Phone: 301-796-8858
Website: www.fda.gov/AdvisoryCommittees/default.htm
As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to
recruit qualified experts with minimal conflicts of interest who are interested
in serving on FDA advisory committees, FDA is requesting nominations for
members to serve on its advisory committees. Please visit the FDA’s Advisory
Committee Oversight and Management Staff booth for details and how to
apply.
Experis Clinical, an industry leading Functional Service Provider is celebrating
our 30th year in serving our pharmaceutical, biotechnology and CRO clients
across North America. We are a niche-CRO focused on Data Management,
Clinical Programming, Biostatistics, Translation Services and automating
manual processes through our Clinical Application Development teams.
EXTEDO, Inc.
Phone: 301-827-2000
The FDA’s Center for Drug Evaluation and Research (CDER) makes sure that
safe and effective drugs are available to improve the health of the American
people. CDER ensures that prescription and over-the-counter drugs, both
brand name and generic, work correctly and that the health benefits outweigh known risks.
ExL Pharma, a division of ExL Events, Inc., develops innovative, educational
forums that serve the pharmaceutical and allied healthcare communities in
the United States, Europe and Latin America. Our primary market sectors
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Experis Clinical Practice
Booth: 1614
Contact: Patricia Harley
Website: www.fda.gov
The Center for Biologics Evaluation and Research (CBER) in the Food and
Drug Administration’s (FDA) - a U.S. government agency - regulates biological products such as vaccines, blood, blood products, allergenics, cells,
tissues, and gene therapy products for human use. Knowledgeable staff
provides information on the regulation of biological products.
ExecuPharm (EP) provides a variety of clinical research workforce solutions from individual placement to functional outsourcing. With significant
hands-on industry experience, the ExecuPharm Clinical Management team
will partner with you to develop innovative, cost-effective solutions to your
needs. Put the EP power of experience to work for you.
ExL Pharma
FDA/CBER
FDAnews
Booth: 1107
Contact: Nelly Valentin
Website: www.fdanews.com
Phone: 703-538-7600
FDAnews publishes domestic and international regulatory, legislative and
business news and information for executives in industries regulated by the
U.S. Food and Drug Administration. Pharmaceutical and medical device
professionals rely on FDAnews’ print and electronic newsletters, books, management reports and conferences to stay in compliance with international
standards and FDA’s complex and ever-changing regulations to get their
products to market faster and boost profits.
EXTEDO is the key solution and services provider in the field of Regulatory
Information Management. The complete EXTEDOsuite is unique in all that
it covers, including product registration planning and tracking; submission
management, pharmacovigilance management, label management and
document management. Today EXTEDO serves more than 700 customers 57
countries. EXTEDO is recognized as one of the leaders in each of its areas of
operations.
165
FIRST Robotics
Booth: 1101
Contact: Donald Bowers
Phone: 908-635-9180
Exhibitor Directory
Flex Databases
Booth: 3209
Fujitsu Limited
Contact: Natalia Blagodarova
Email: contactus@flexdatabases.com
Website: www.flexdatabases.com
Phone: +7-812-332-5915
Contact: Hajime Kosuge
Phone: +81-362-522-366
Website: www.fujitsu.com/global/
Booth: 1449
Flex Databases is a software & consulting company specializing in automation of internal business processes in Contract Research Organizations. Our
web-based solutions are intended to enhance the efficiency of business
processes and streamline operations and development activities by optimizing the design, planning and management of key aspects of any CRO. Our
products: CTMS, Investigators & Sites Management, Project Catalogue, Time
Sheets & Utilization, HR, Learning Management System and other.
Fujitsu is the leading Japanese information and communication technology
(ICT) company and the world’s third-largest IT services provider offering a
full range of technology products, solutions and services in more than 100
countries. Among its life science portfolio, DDworks21 has been recognized
as the leading software solution for clinical trial quality and regulatory compliance in Japan. Fujitsu is transforming DDworks21 into a global GCP Risk
Management solution in the US in 2012.
Foresight Group, LLC
Booth: 3238
Fundacion De Investigacion
Contact: Janice Scheider
Website: www.foresightgroup.com
Phone: 888-992-8880
Booth: 3048
Business Suite: BS6
Contact: Francisco G. Bruno, COO, CFO
Phone: 787-722-1248
Website: www.fundaciondeinvestigacion.com
Since 2005, Foresight Group International AG is a global team of experienced
professionals dedicated to discovering and implementing the ideal solutions
for clients in the life science industry. Foresight Services and solutions include
implementing and upgrading safety systems, data migration, business process & transition, PV Monitor® a solution that supports compliance monitoring, and regulatory affairs services including packaging and labeling.
Located in San Juan, Puerto Rico, Fundación de Investigación (FDI) is a clinical research center and medical care facility for patients with liver diseases,
metabolic disorders, oncological, neurological, musculoskeletal and infectious
diseases. FDI’s facilities include a phase I unit, a bioanalytical laboratory,
multispecialty-experienced personnel, and the latest in medical technology.
Formedix Inc
Booth: 2148
Global Instrumentation LLC
Contact: Nicola Rogerson
Website: www.formedix.com
Phone: 781-685-4995
Contact: James DeMaso
Phone: 315-727-6659
Website: www.GlobalInstrumentation.com
Global Instrumentations M12R ECG acquisition units combined with the M12A
Enterprise application provide a turn-key solution to meet the requirements
of clinical research. This platform supports a seamless exchange of ECG
data from investigator sites to a centralized location including the export of
FDA-HL7 data.
Our clinical trial automation software, the Formedix Origin and Transform
suite, coupled with consultancy services enables you to remove manual,
expensive, inefficient and labor intensive tasks from study set-up, EDC build,
validation and submission publication processes. In facts, across every area
of your end-to-end clinical trial, the time and cost savings we deliver speak
for themselves and continue to do so time and time again... YOUR CLINICAL
TRIALS AUTOMATED. EVERYWHERE.
Forte Reseach Systems, Inc
Booth: 1951
Contact: Brian Wulff
Website: www.forteresearch.com
Phone: 608-826-6002
Booth: 1116
Contact: Ajay Sharma, Ph.D., MBA
Website: www.frontagelab.com
Phone: 484-879-1601
Global Language Solutions
Booth: 2108
Contact: Inna Kassatkina
Phone: 949-798-1400 Ext. 222
Website: www.globallanguages.com
Global Language Solutions (GLS) is an ISO 9001:2008 and EN 15038 certified
translation and interpreting company specializing in pharmaceutical, biotechnology, and medical device translations in over 100 languages. Our medical
linguists have experience translating IFUs, ICFs, patents, manuals, packaging
and labels, and websites. GLS was founded in 1994 and is a certified WBE.
Forte Research Systems develops specialized clinical trial management
systems designed with the specific needs of different research organizations
in mind. The company’s cloud-based Allegro® Research on Demand product
line includes the Allegro CTMS@Network™ system for trial and site management organizations and investigator site networks. For investigator sites
and research groups, the company has developed the Allegro CTMS@Site™
system.
Frontage
Booth: 1641
GlobalCare Clinical Trials, LTD
Booth: 1148
Contact: Gail Adinamis
Website: www.globalcarect.com
Phone: 847-282-3280
GlobalCare conducts study visits (eg. blood draws, drug admin) at patients’
homes or other convenient locations via its global network of traveling
clinicians to facilitate trials in a variety of indications and all phases and age
groups. Globalcare’s patient-centric approach provides faster patient recruitment and better compliance/retention.
Founded in 2001, Frontage is a global contract research, development and
manufacturing organization, offering a full range of pharmaceutical R&D services. Operating in the US and China using one seamless GXP platform (GMP/
GLP/GCP), Frontage runs three Phase 1 Clinical units, an 88-bed Phase 1 Unit
in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province
China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China.
166
Exhibitor Directory
GlobalSubmit, Inc.
Booth: 1203
HCRAmerica
Booth: 2744
Contact: Jen Watto
Website: www.globalsubmit.com
Phone: 215-564-6837
Contact: Donna Berk
Website: www.harrisonclinical.com
Phone: 609-987-1700
HCRAmerica is the US of Harrison Clinical Research, an international CRO
perating since 1987 with offices throughout Europe, Israel and the USA offering our clients a full service solution for clinical research projects, both globally and locally. Our experienced staff provide a strong dedicated team for
your projects in the clinical research area as a completely outsourced project
or as individual tasks alone.
GlobalSubmit is a products and services company that provides transparency
in regulated healthcare products. The U.S. Food & Drug Administration and
leading Life Sciences companies use our flagship applications, REVIEW™ and
VALIDATE™, to review and validate electronic submissions. GlobalSubmit’s
thought leaders direct international efforts, constantly working with industry
and government agencies to standardize product and study information.
Healthcare Communications Group Booth: 1413
goBalto, Inc.
Booth: 1114
Contact: Zach Hector
Website: www.gobalto.com/
Phone: 415-671-4372
Contact: Linda Kilpatrick
Website: www.hcg.com
HCG has over fourteen years of experience in providing global and U.S.
clinical trial subject enrollment and retention solutions that reduce timelines
for challenging studies. Our proven Recruit to Retain™ strategies integrate
new technologies with traditional relationship-building. We partner with our
clients to ensure optimal program outcomes.
goBalto develops web-based solutions that simplify how clinical trials
are conducted in the pharmaceutical, biotechnology and medical device
industries. Tracker™, launched in June 2011, is a purpose-built Softwareas-a-Service clinical research tool that enables clinical trials sponsors to
collaborate with multiple partners directly from the web in a transparent and
regulatory compliant manner.
Green Key Resources
Booth: 1743
Contact: Cheryl Chasen
Website: www.greenkeypharma.com/
Phone: 212-683-1988
Booth: 3125
Contact: Brad Miklavic
Website: www.greenphire.com
Phone: 215-609-4378
Booth: 2503
Greenway Medical Technologies’ PrimeResearch Network leverages
Greenway’s award-winning and certified Electronic Health Record (EHR) - to
ease feasibility, increase recruitment, simplify data collection and provide
remote monitoring - a smarter way to achieve research.
Booth: 2633
Contact: Fanqiang Meng
Website: www.hjcro.com
Phone: 732-354-0908
Phone: 757-304-7273
High Point Solutions
Booth: 1033
I.D.E.A. Ltd.
Booth: 2050
Contact: Tamsyn Frost
Website: www.eurepresentative.com
Phone: 44-122-340-2666
EU Legal Representative services for non-EU Sponsors wishing to conduct
Clinical Trials and/or hold Orphan Drug Designations within the European
Union. I.D.E.A. specializes in assisting the Sponsors it represents to conduct
their EU clinical trials in compliance with EU Legislation and Guidelines, and
guide them through the European Medicines Agency’s orphan drug designation processes.
Phone: 678-836-3100
Website: www.greenwaymedical.com
H&J CRO International, Inc.
Booth: 1548
Contact: Emma Hemed
HighPoint Solutions solves the toughest IT challenges facing companies in
the highly regulated life sciences and healthcare industries by providing our
clients with practical IT strategies and solution implementations and giving
them direct access to the people and technology that get things done. Since
2000, our 400 consultants have provided business consulting and technology solutions that continue to deliver business value and competitive advantage to more than 140 clients nationwide.
Greenphire is the leading provider of clinical payment solutions. Greenphire’s
globally scalable technologies—the ClinCard System and eClinicalGPS—
enable users (sponsors, CROs, and sites) to electronically calculate, approve,
and deliver payments to investigators, vendors, and trial participants.
Greenphire’s solutions currently support 60,000 subjects across 11,000 studies at 1,600 clinical trial sites.
Greenway Medical Technologies
Heat In A Click
Contact: Kristen Carmean
Phone: 610-233-2708
Website: www.highpoint-solutions.com
Green Key Resources is one of the fastest growing professional recruitment firms offering a complete portfolio of staffing solutions, including
temporary and contract staffing, executive search, and payroll services to
leading Pharmaceutical, Biotechnology, Medical Device, and CRO companies
nationwide.
Greenphire
Phone: 310-606-5700
iCardiac Technologies
Booth: 1526
Contact: Sasha Latypova
Website: www.icardiac.com/
Phone: 617-359-7088
iCardiac Technologies, Inc. is a technologically-differentiated cardiac core lab
providing the industry’s most sophisticated ICH E14 compliant cardiac safety
assessment methodologies for clinical studies, supported by scientific expertise, project management, worldwide site and equipment logistics, customer
support and regulatory data submission.
H&J is a Leading Full-Service CRO in China Offering Your Global Clinical Trial
Solutions. Established in 2003, headquartered in New Jersey, with17 branch
offices in China major cities, it has more than 200 full time employees worldwide. The only China CRO capable to provide protocol/CRF/ICF/IB development, DM & SA services for American R&D. 167
Exhibitor Directory
ICON plc
Booth: 2701
Inamed GmbH
Booth: 2501
Contact: Erica Hill
Website: www.iconplc.com
Phone: 215-616-3286
Contact: Patrick McManus
Website: www.inamed-cro.com
Phone: +49-898-935-6929
ICON is one of the largest providers of outsourced development services to
the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs
that support clinical development - from compound selection to Phase I-IV
clinical studies. With our global footprint and expertise and our commitment
to excellence, we can help clients maximize the effectiveness of their R&D
activities, with a focus on reducing fixed costs.
Inamed is an international contract research organization with true respiratory expertise. Complementing our solid experience in conducting clinical
trials, Inamed’s team of inhalation and clinical experts provides our sponsors
with a unique spectrum of services. Besides our clinical trial operations Phase
IIb-IV and fully staffed, in-house Phase I-IIa unit with twenty beds, Inamed
performs in-vitro studies in our own labs and is leading in performing scintigraphic lung deposition studies.
Idem Translations, Inc.
Booth: 2848
INC Research
Booth: 1901
Contact: Nancy Kellen
Website: www.idemtranslations.com
Phone: 650-858-4336
Contact: Tim Dietlin
Website: www.incresearch.com
Phone: 919-876-9300
IDEM TRANSLATIONS, YOUR TRUSTED PARTNER FOR OVER 27 YEARS,
SUPPORTING CERTIFIED MEDICAL TRANSLATION NEEDS FROM CLINICAL
TRIAL STAGES TO PRODUCT LAUNCH AND MAINTENANCE. Expert
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Documentation Idem is ISO 9001:2008 and WBENC certified. We look
forward to meeting you at the conference and learning about your language
needs!
IFAPP
Booth: 1848
Contact: Jargalmaa Undeejav
Phone: +65-963-612-13
Illingworth Research
Booth: 1948
Contact: John Illingworth
Website: www.illingworthresearch.com
Phone: +44 1625 617447
INC Research is a leading global CRO providing the full range of Phase I to
IV clinical development services across six continents through our global
scale and scope, broad therapeutic expertise and commitment to operational
excellence using our proven Trusted Process®.
Booth: 2600
Contact: Chuck Klotz
Website: www.imperialcrs.com
Phone: 616-802-1940
Booth: 2851
Contact: Dan Maier
Website: www.decisionview.com
Phone: 415-538-1800
Phone: 910-332-2682
Indipharm
Booth: 1635
Contact: Ed Brennan
Website: www.indipharm.com
Phone: 610-230-0126
IndiPharm is a Clinical Services Organization, based in the U.S. with operational centers in Mumbai, India. We provide full service clinical trial and
pharmacovigilance services to pharma, biotech and medical device companies looking to lower their operational costs, while still achieving the highest
quality standards. IndiPharm’s leadership team brings decades of successful
experience conducting clinical trials and pharmacovigilance around the world
to meet Western regulatory standards.
Serving the life science industry for more than four decades, Imperial is a
trusted solutions provider to sponsors and CRO’s alike. Focused in clinical
trials, Imperial offers a unique service and product offering including
design from protocol, ISO certified translation management, site material
production and fulfillment, and a logistics team responsible for 50,000+
global shipments each year. Contact us at 800.777.2591 or visit us at
www.imperialcrs.com.
IMS Health/DecisionView
Booth: 3245
Contact: Kristin Kinlaw
Website: www.inclinix.com
Inclinix delivers a site-focused approach to patient recruitment that ensures
every available study candidate is identified, qualified and presented with
a study opportunity. Pharma, biotech and medical device Sponsors benefit
from 12 years of experience in multiple therapeutic areas, as well as leading
edge technologies that meet the challenge of clinical development from
feasibility and site selection through patient retention and compliance.
Illingworth Research is a leading European CRO providing a wide range of
clinical development and medical photography services to companies both
large and small involved in clinical trials. Our sister company ResearchNurses.
co specialise in the provision of highly experienced research nurses for both
on-site and homecare projects for the pharmaceutical, healthcare, biotechnology and medical device industries. We are now the UK’s leading independent research nurse provider.
Imperial
Inclinix, Inc.
INNOPHARMA S.r.L.
Booth: 2630
Contact: Massimiliano Stasi
Website: www.innopharma.it
Phone: +39-0362-573-128
Description: INNOPHARMA, a CRO founded in 1995, has the people,
resources, culture to respond to pharmaceutical and biotechnology clients’
toughest drug development challenges. We are one of a small group of
organizations with the capability and expertise to conduct clinical trials and
develop projects on either a local or international basis. Services: Study
Feasibility, Sites Recruitment, Project Management, Patient Recruitment, Trial
Monitoring, eCRF, CSR, EDC, IVRS, Medical Writing, QA.
DecisionView, an IMS company, develops innovative web-based software
solutions that enable life sciences organizations around the world to improve
site selection and patient enrollment. DecisionView products are used by 8 of
the top 10 global pharmaceutical companies, and have been used on clinical
studies with over 450,000 subjects enrolled in 17 different therapeutic areas.
168
Exhibitor Directory
Innovative Print & Media Group
Booth: 2850
IntraLinks, Inc.
Booth: 3131
Contact: Gilbert Rolon
Website: www.innoprint.com
Phone: 610-389-7510
Contact: Valerie-Ann Lebo
Website: www.intralinks.com
Phone: 212-342-7556
Innovative Print & Media Group is your essential resource for Print, fulfillment
and Direct Mail. We specialize in Providing Print Solutions to the Pharma
Industry, including Printed materials, promotional products, real time order
tracking and e-learning tools.
Integrated Clinical Systems, Inc.
Booth: 1242
Contact: Eric Herbel
Website: www.i-review.com
Phone: 908-996-3312
IntraLinks provides a secure, online environment where study teams, investigator sites, CROs and IRBs manage, distribute and store critical study documents. Let IntraLinks transform your business by speeding up the clinical
trial process, improving operational efficiencies and ensuring the immediate
exchange of your safety and study documentation.
Institute for International Research Booth: 1649
Integrated Clinical Systems - developers of Integrated Review(tm) and
JReview(r) the fastest and easiest way to review, graph, visualize, report,
analyze, do patient profiles and patient narratives for your clinical data.
Works with OC, Clintrial, SAS datasets, Oracle LSH, SAS DD, Oracle CDC,
Rave, Inform, etc.
IntegReview IRB
Booth: 3102
Contact: Rick Clemens
Website: www.integreview.com
Phone: 512-326-3001
Contact: Silvia A. Trinidad, CEO
Website: www.intldermresearch.com/
Booth: 3215
Booth: 1637
Contact: Anna Metcalfe
Phone: 905-542-2900 Ext. 292
Booth: 3312
Phone: +91-079-665-2703-7
IRB Services
Booth: 1550
Contact: Simon Corman
Website: www.irbservices.com
Phone: 905-727-7989 Ext. 257
invivodata
Booth: 1416
Business Suite: BS5
Contact: Jodi Andrews
Website: www.invivodata.com/
Phone: 412-390-3000
invivodata is the industry’s only fully-integrated company that delivers comprehensive Clinical Outcome Assessments (COAs) solutions (PROs, ClinROs
& ObsROs) to biopharmaceutical companies who depend upon patientcentered research. Visit www.invivodata.com for more information.
Website: www.cantox.com
Intertek Cantox is a leading international scientific and regulatory consulting
firm. With diverse and in-depth experience in pharmaceutical development,
our resourceful and innovative team in the Pharmaceutical and Healthcare
Group consists of regulatory affairs professionals, board-certified toxicologists, and scientific writers.
Contact: Devina Bhardwaj
Website: www.interveinlab.com
Booth: 3008
Fully AAHRPP Accredited, IRB SERVICES is a well established & respected
central IRB, since 1993. Physical Boards in Ontario, Quebec, and Florida, we
provide North America-wide service. Human Research Protection, excellence in service, quality, and efficiency are at the core of our mission. Multiple
weekly meetings & dedicated service teams provide Real Reviews... In Real
Time.
Phone: 305-225-0400
Intervein Laboratories Pvt. Ltd.
Investigator Support Services
At no cost to sponsors/CROs, ISS matches top performing sites from our
fully vetted network of 2700 investigators across the US, Canada, Mexico and
India for phase I-IV trials across all therapeutic areas. We also support global
patient recruitment, retention, compliance, pharmacovigilance and post-marketing programs with 24/7 contact center solutions. We are a single-source
provider of patient, consumer and healthcare professional communication
services in over 20 languages.
International Dermatology Research, Inc. is a research Site specializing in
dermatology. Headquartered in Miami, Florida it provides state-of-the-art
facilities, a highly qualified staff and 9 additional sites in Latin America. Over
the past 19 years IDR has gained excellent recognition for conducting successful Phase II, III and IV studies.
Intertek Cantox
Phone: 646-895-7475
Contact: Sarah Ebner
Phone: 773-278-1567
Website: www.researchsite.net/index.html
IntegReview IRB, AAHRP accredited, provides six weekly meetings, including
Canadian review, Latin American review, same day site review, thorough,
prompt, and knowledgeable IRB review along with consulting, available,
responsive staff, quality assurance and quality control, electronic submissions
and web portal access to study documents within 1-2 days of board review.
International Dermatology Research, Inc.
Contact: Adam Lennon
Italian Medicines Agency
Booth: 1615
Contact: Gabriella Conti,
Head of International Relations
Phone: +39-0659784615
Website: aifa.gov.it
The Italian Medicines Agency (AIFA) is the national competent authority for:
· Marketing authorisation of medicinal products · Pharmacovigilance · Clinical
trials · Inspections of products and manufacturing process · Independent
information · Price and Reimbursement
169
Exhibitor Directory
JANIX CRO
Booth: 2617
Website: www.JANIX.com
JANIX is a full service CRO with global operations in North America, Europe,
Africa, Israel, and Asia Pacific. We offer trial management, monitoring,
patient recruitment, data management biostatistics, QA, RA, medical affairs,
and REMS. We perform Phase I-IV pharma & device studies and marketing,
registration, outcomes, nutra & cosmeceutical trials.
Joule Clinical Staffing Solutions
Booth: 1832
Contact: Amanda Wahl
Website: www.jouleclinical.com/
Phone: 800-382-0382
Booth: 3424
Contact: Betsy Clarke
Website: www.clinsys.com
Phone: 908-947-7756
Booth: 1543
Contact: Marissa Carnevale
Website: www.judge.com
Phone: 732-346-9100
Booth: 1019
Contact: Thomas F. Krol, PharmD, CLP
Website: www.kansasbioauthority.org
Phone: 913-397-8300
Kelly Scientific Resources
Booth: 1200
Contact: Diane Barker
Website: www.kellyservices.us/science
Phone: 314-439-5649
Klein Hersh International
Booth: 3213
Contact: Jason Hersh
Website: www.kleinhersh.com
Phone: 215-830-9211 Ext. 104
Klein Hersh International is the industry leader in Life Sciences Executive
Search. As a full service search firm, we provide retained & contingency
search as well as contract staffing in Clinical, Regulatory, and Healthcare IT
functions throughout the drug development lifecycle. Visit us on the web at
www.kleinhersh.com.
KoNECT
Booth: 1519
Contact: Julie Lee
Website: KoNECT.or.kr
Phone: +82-236-687-609
As a government funded organization responsible for expanding the infrastructure of clinical trials in Korea, Korea National Enterprise for Clinical Trials
(KoNECT) manages regional clinical trial centers, operates clinical trials training academies and provides clinical trial technology development programs.
KoNECT is leading the way in promoting Korea as the global hub of clinical
trials.
Looking for a new Career? The Judge Group has been recruiting Scientific
& Clinical Professionals to work in the nation’s leading Pharmaceutical &
Biotech companies since 1970. Whether you’re looking for a permanent or
contract position, you can be sure Judge will work with you every step of the
way to ensure your next career move is the right one!
Kansas Bioscience Authority
Phone: 215-966-6055
Kelly Services specializes in clinical research solutions and has years of experience as a strategic partner to help your business reach critical goals. We
build custom workforce plans as well as project-based solutions, including a
synchronized approach to outsourced clinical trial management, helping you
save money and increase speed to market.
Jubilant Clinsys Inc. is a global, full-service, scientifically-focused contract
research organization that provides pharmaceutical, biotechnology and
medical device companies with a full range of services in support of Phase
l - lV drug and device development. The company is a subsidiary of Jubilant
Life Sciences and a fully integrated partner with Jubilant Biosys and Jubilant
Chemsys. Founded in 1992, the company has offices in NJ and NC, USA,
Canada, India and Germany.
The Judge Group
Booth: 1348
Contact: Orelie Cathaud
Website: www.kayentis.com
Kayentis www.kayentis.com, the leader in digital pen and paper solutions,
provides the optimal paper-based e-data capture solutions for clinical trials. It offers the easiest and most reliable data collection method for both
patients and physicians (pen & paper), resulting in the highest quality
captured data. Kayentis solutions are based on Anoto Digital Pen & Paper
technology; Kayentis is one of the leading world partners of Anoto, and is
certified Anoto Platinum Partner.
At Joulé Clinical Staffing you could say the right match is in our DNA. For
more than 20 years we’ve connected pharmaceutical, biotech, clinical
research and medical device firms to professionals nationwide. Our specialized experience and network enable us to provide the most qualified clinical
research, regulatory and drug safety specialists. Recognized for superior
service, Joulé provides complete solutions including contract, temporary,
project and direct hire. The Right Match is in our DNA.
Jubilant Clinsys Inc.
Kayentis
Kramer Translations
Booth: 1748
Contact: Keith Ensminger
Website: www.kramertranslations.com
Phone: 209-385-0425
Kramer Translation and our network professional writers can translate your
medical documents from initial copy to final print with a translation process
that meets or exceeds ISO9001:2008 and EN15038 standards. Please visit us
atBooth 1748 to learn how we can assist your medical research.
The Kansas Bioscience Authority was created by the state to accelerate
growth in the promising bioscience sector. Funded by Kansas income taxes
generated by bioscience jobs, KBA investments help create high-paying jobs,
and encourage private capital investments in Kansas bioscience companies.
The KBA is a partner in promoting Bio Research Central, home to more than
90 CROs and clinical service providers that generate an estimated $1.33 billion in annual revenue in the Kansas City area.
LabConnect, LLC
Booth: 3137
Contact: Dan Knabb
Website: www.labconnectllc.com
Phone: 206-322-4680
Founded in 2002, LabConnect provides central laboratory and laboratory
management services for the biopharmaceutical industry through a global
network of exceptional, high-capacity laboratories. This unique approach
puts our focus on providing our clients with high-value central laboratory
services (logistics, project management, test kits) and the finest proprietary
data management and reporting technologies in the industry.
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Exhibitor Directory
LabCorp Clinical Trials
Booth: 2405
Liquent
Booth: 1124
Contact: Shailesh Maingi
Website: www.labcorp.com/clinicaltrials
Phone: 877-788-8861
Contact: Jennifer Mattera
Website: www.liquent.com
Phone: 215-328-4489
LabCorp Clinical Trials supports pharmaceutical companies globally with
efficient & innovative laboratory testing services for clinical trials programs.
LabCorp Clinical Trials provides a broad portfolio of state-of-the-art laboratory services to support all aspects of centralized testing at wholly owned
central labs in Belgium, China, Singapore, and the U.S. – including Phase I-IV
trials, esoteric testing, biomarker development and validation, new method
development, and companion diagnostics.
Leadership Directories Inc.
LIQUENT provides technology and outsourcing solutions focused around
regulatory submission preparation and tasks, dossier planning, eCTD to CTD
publishing and registration tracking capabilities. LIQUENT is the premier
provider of a scalable, regulatory information management platform and
associated regulatory & clinical services.
Booth: 1827
Contact: Catherine Buscemi
Phone: 212-627-4140 Ext. 3338
Booth: 2944
Contact: Jill Huentelman
Website: www.lernia-ts.com
Phone: 610-356-1792
Founded in 2000, Lernia Training Solutions LLC specializes in the creation,
deliver and management of training to the life sciences industry.
Life Science Leader
Booth: 1109
Contact: Sean Hoffman
Website: www.lifescienceleader.com
Phone: 724-940-7555
Booth: 3428
Contact: Gerald Matczak
Website: www.lillycoi.com
Phone: 317-433-6764
LORENZ Life Sciences Group
Booth: 1924
Contact: Petra Mc Grath
Website: www.lorenz.cc
Phone: +49-697-899-1144
Lovelace Scientific Resources
Booth: 1112
Contact: Sally Trujillo
Website: www.Lsrtrials.com
Phone: 505-348-9500
Lovelace Scientific Resources is a clinical trials company that specializes in
conducting Phase II-IV outpatient, multi-therapeutic trials with over-night
capability. Our research facilities are independently operated and are affiliated with Physician Investigator practices. Locations include Albuquerque
NM, Austin TX, Sarasota/Venice FL.
Eli Lilly Clinical Open Innovation believes clinical research and development
can be transformed by using open tools and data. We engage in the open
for insight, innovation, talent and wisdom to drive new capabilities to fight
disease and meet patient needs. Stop by to explore how our free, open
access tools help you plan and design clinical trials, as well as consider how
a disease commons approach can assist in the fight against disease. We look
forward to meeting you and sharing ideas.
Lionbridge Life Sciences
Phone: +44-845-838-5900
LORENZ is the most established provider of e-regulatory software and services in the world, focused on submission management, labelling and tracking. The products don’t require the purchase of continual services to get the
job done. LORENZ’ solutions foster independence, empowering customers to
develop their own processes.
Life Science Leader strives to be an essential business tool for Life Science
executives. The editorial is designed to provide readers with content pertaining to the life cycle of Life Science products and services. Our goal is to
provide information that helps high-level industry personnel improve profits
and overcome hurdles within the industry.
Lilly Clinical Open Innovation
Booth: 2041
Contact: Giles Wilson
Website: www.logostechnologies.com
ALPHADAS®, is the market leading e-Source, pro-active EDC and site automation system for Early Phase clinical trials which addresses the needs of
investigators and sponsors alike through its sophisticated integration abilities.
ALPHADAS is a mobile, schedule-driven event based system which provides
real-time pro-active EDC at the bedside, station or remote location. It is a
world class, proven product used by early phase CRO’s and top 10 pharmaceuticals, globally, providing an exceptional ROI.
Website: www.leadershipdirectories.com
Leadership Directories builds web-based directories which include accurate
contacts at healthcare organizations, companies, government agencies,
Congressional offices, law firms, media outlets, and nonprofits.
Lernia Training Solutions
Logos Technologies Inc.
Lyophilization Technology, Inc.
Booth: 2048
Contact: Edward Trappler
Website: www.lyotechnology.com
Phone: 215-396-8373
Lyophilization Technology, Inc. is a Contract Development and Manufacturing
Organization providing development and technical services focused on
lyophilized products. The comprehensive range of services includes product
design, formulation development, process engineering, clinical supplies
manufacturing for freeze dried pharmaceuticals, biologics, diagnostics, biopharmaceuticals and fine chemicals. Technical services encompass consulting, compliance support and training.
Booth: 2436
Contact: Tiana Pignone
Phone: 978-964-4886
Website: www.lionbridgelifesciences.com/
Lionbridge Life Sciences is the leading provider of language services to
medical device developers, pharmaceutical and biotechnology companies,
and CROs. We specialize in high-quality translation, linguistic validation, and
interpretation services in 150+ languages. Lionbridge Life Sciences clients
benefit from our highly specialized network of medically trained linguists,
operating in over 40 full-service solution centers across 26 countries.
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Exhibitor Directory
MakroCare
MaxisIT Inc.
Booth: 2417
Contact: Subrata Biswas
Phone: 973-481-0100 Ext. 2026
Contact: Maulik Shah
Website: www.maxisit.com
Phone: 732-494-2005 Ext. 101
Website: www.makrocare.com
MakroCare is a global drug development and commercialization services firm
that has 12 international offices and serves clients through 5 main divisions —
DDi, CRO, SMO, Commercialization and Regulatory Consulting. It offers integrated and innovative services in USA, Europe and Asia by its unique blend
of regulatory, medical, clinical, project management backed by completely
validated eClinical suite including mEDC, mCTMS, mIWRS, mCoder and other
tools.
MaxisIT offers integrated data, analytics and regulatory content management
platform CTRenaissance® as managed hosting and software-as-a-service,
which empowers pharmaceuticals, life sciences and academic organizations with web-based and scalable environment to design, manage, monitor
clinical trials as well as analyze and submit data on-demand in most efficient
manner. A unique and successful blend of clinical trial software and services
in compliance to regulatory and industry data standards.
Malvern Consulting Group, Inc.
Booth: 1833
Booth: 3348
Contact: Sue Sharr
Phone: 484-395-2420
Website: www.malvernconsultinggroup.com
Booth: 3250
Contact: Scott Baldwin
Website: www.masimo.com
Phone: 949-297-7000
Masimo is a global medical technology company that develops and manufactures innovative noninvasive technologies, medical devices and sensors that
may enable earlier detection and treatment of potentially life-threatening
conditions—offers numerous award-winning patient monitoring solutions,
including Masimo SET®, Masimo rainbow SET® noninvasive and continuous
hemoglobin (SpHb®), acoustic respiration rate (RRa™), Masimo SafetyNet™,
and SEDLine® (EEG-based) Brain Function Monitors.
Phone: 617-732-2988
Booth: 1441
Contact: Emily O’Driscoll
Website: www.mastercontrol.com
Phone: 801-942-4000
MedDRA MSSO
Booth: 1201
Contact: Char Guy
Website: www.meddramsso.com
Phone: 571-313-2395
Medical Research Network Ltd.
Booth: 2745
Contact: Stuart Redding
Website: www.themrn.co.uk
Phone: +44-190-1908 261153
Established in 2006, the MRN is the world’s leading provider of home
healthcare nursing for patients in clinical trials, with coverage now spanning 4
continents. Our focus is patient recruitment and retention, as well as offering
at home visits, we can also provide nursing staff to sites where resources may
be constrained.
Massachusetts College of Pharmacy and Health Sciences (MCPHS) offers
exciting opportunities for those interested a graduate education in health
care. To accommodate unique personal and professional schedules, students
can enroll in programs as full-time or part-time studies at either our Boston
Campus or Online Campus.
Master Control
Phone: 804-675-5151
MedDRA is a clinically validated terminology used for encoding adverse
events for the biopharmaceutical industry and regulators. The MSSO maintains MedDRA and provides support services (e.g., training, data conversion,
consulting).
Massachusetts College of Pharmacy
and Health Sciences
Booth: 3005
Contact: Julie George
Website: www.mcphs.edu
Booth: 1836
Contact: Robert Dresch
Website: vaww.research.va.gov
McGuire Research Institute (MRI) was established in 1989 and conducts
Phase 1-4 clinical trials. MRI is affiliated with the Richmond VA Medical Center
and has a 35,000 patient panel. IRB meets weekly, AAHRPP accredited
human research protection program. Special expertise in diabetes, lipids,
Hep C, Crohn’s, colitis, interventional cardiology, electrophysiology, DVT,
Parkinson’s, spinal cord injury, traumatic brain injury.
Malvern Consulting Group is comprised of a team of professionals with
diverse backgrounds and expertise encompassing all disciplines of product
development: pre-clinical, clinical, regulatory, quality, manufacturing, and
packaging.
MASIMO
McGuire Research Institute
Medicines Evaluation Unit
Booth: 1026
Contact: Sam Warburton
Website: meu.org.uk
Phone: +44-161-946-4058
The Medicines Evaluation Unit (MEU) is a clinical trials unit that specializes in
respiratory diseases, including Asthma and COPD.
MasterControl Inc. produces software solutions for the life sciences industry which include management solutions for enterprise quality assurance/
control, enterprise documents, product lifecycle, GxP audit, training, bill of
materials, suppliers, submission organization and archiving, clinical trial master files and more. Supported by a comprehensive array of services based on
industry best practices, MasterControl provides our customers with complete
solution across the entire enterprise.
Medidata Solutions Worldwide
Booth: 3101
Contact: Global Sales
Website: www.mdsol.com
Phone: 212-918-1800
Medidata Solutions is a leading global provider of SaaS clinical development
solutions that enhance the efficiency of clinical trials. Our advanced solutions
lower the total cost of clinical development by optimizing trials from concept
to conclusion, serving a diverse and growing customer base.
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Exhibitor Directory
MedNet Solutions, Inc.
Booth: 3017
Merge eClinical
Booth: 2601
Contact: Dirk Nelson
Website: www.mednetstudy.com
Phone: 763-258-2735
Contact: Courtney Smith
Website: www.merge.com
Phone: 919-653-3425
MedNet is a leading eClinical technology solutions company specializing in
electronic data capture (EDC) and clinical study management systems. Since
2000, MedNet’s proven web-based solutions have successfully supported
research initiatives worldwide. Visit our booth to see iMedNet EDC…an
affordable new solution that allows sponsors and CROs to quickly and easily
build their own studies.
Medpace Inc.
Booth: 2413
Contact: Jennifer Hammonds
Website: www.medpace.com/
Phone: 513-579-9911
Merge Healthcare is a leading provider of enterprise imaging and interoperability solutions. Merge solutions facilitate the sharing of images to improve
the electronic healthcare experience. Merge provides solutions for radiology,
cardiology, orthopaedics, eye care, clinical trials, financial and pre-surgical
management; electronic health record and practice management solutions;
applications that fuel the largest modality vendors in the world, and a network of patient-centric wellness stations.
Medpace, Inc. is a global, full-service Contract Research Organization
specializing in the therapeutic areas of cardiology, metabolism, oncology,
neurology, and infectious disease. Our guiding philosophy is to provide the
best therapeutic and regulatory expertise at each stage of the drug/device
development process. Medpace provides central reference laboratory services, bioanalytical laboratory services, human pharmacology, imaging core
lab, ECG reading support, and device trial management.
MedSource
Booth: 1417
Contact: Eric Lund
Website: www.medsource.com
Phone: 281-286-2003
Booth: 2439
Contact: Pam Mandich
Website: www.medtox.com/clinicaltrials
Phone: 651-628-6175
Booth: 2517
Contact: David Pfennig
Website: www.metasol.com
Phone: 908-393-9906
META Solutions, Inc. is a regulatory compliance consultancy with 25 years
of experience assisting over 300 biopharmaceutical and related service
companies in managing their regulatory compliance risk by assessing noncompliance and developing and implementing practical solutions with expert
guidance and training. Our core expertise includes GxP auditing, computer
validation remediation and consulting, data management, and monitoring
services.
MedSource, a therapeutically focused CRO, specializes in providing support
for the most complex clinical trials. Be it a challenging therapeutic area or
a sophisticated trial design, our highly experienced team always exceeds
expectations. By focusing on our core service offerings, MedSource provides
quality results and client satisfaction.
MEDTOX Laboratories
META Solutions, Inc.
M-Files Inc.
Booth: 1132
Contact: Sasha Vaynman
Email: sales@m-files.com
Website: www.m-files.com/eng/qms.asp
Phone: 972-516-4210 Ext. 122
M-Files QMS is an out-of-the-box solution for daily quality management.
With M-Files QMS, all quality documents and data are linked together within
a single system, enabling organizations to optimize quality processes while
streamlining compliance activities and audit requirements.
Microsoft Corporation
Booth: 1325
Business Suite: BS4
Contact: Mark Fisher
Phone: 425-882-8080
Website: www.microsoft.com/lifesciences
MEDTOX Laboratories is a publicly traded company (MTOX) providing global
bioanalytical, biomarker and central laboratory contract services. Our laboratories use the latest advances in technology and our experienced staff is
responsive, accountable and flexible to meet your changing needs. Services
include: bioanalytical testing, central laboratory, bioequivalence testing, biomarkers, microbiology, woman’s health studies, viral load testing, molecular,
and pathology / IHC.
Life sciences organizations are under pressure to meet regulatory requirements and reduce the time it takes to develop drugs and take them to
market. Microsoft and partners have developed cost-effective solutions that
enable organizations to streamline processes that improve productivity and
deliver information whenever and wherever it is needed. www.microsoft.
com/lifesciences
MedTrials
Booth: 1930
Microsystems
Booth: 1928
Contact: Jamie Edwards
Website: www.medtrials.com
Phone: 214-630-0288
Contact: John McClure
Website: www.microsystems.com
Phone: 610-213-5775
MedTrials is a full-service CRO specialized in providing project specific clinical
trial management solutions. We are committed to exceptional service and
high quality results throughout all phases of clinical development. MedTrials
is a WBENC-certified, women-owned business, and is positioned to meet
your supplier diversity needs.
Microsystems offers DocXtools, a collection of document assessment,
cleanup and problem-solving tools that helps medical writers, submission
authors and QC/Compliance departments prevent document problems and
produce high-quality Word documents more quickly. Pharmaceutical companies rely on DocXtools to ensure conformity with house styles and FDA/EMA
guidelines prior to eCTD submissions.
173
Exhibitor Directory
Mission3
Booth: 1118
myClin
Booth: 1941
Contact: Ali Tate
Website: www.mission3.com
Phone: 602-957-2150
Contact: James Denmark
Website: www.myclin.com/
Phone: 877-211-8297
Mission3 is the premier Regulatory Information Management software
provider for the Life Sciences industry. Mission3 provides the only platformbased and integrated Regulatory Information Management solution,
GlobalTrack, a business intelligence platform that provides companies with
increased visibility into their global regulatory initiatives. GlobalTrack is built
on the Microsoft’s SharePoint 2010 and Project Server platform, increasing
user compatibility with their current systems.
MMG
Booth: 2331
Contact: Angelica Carter
Website: www.wegetpatients.com
Phone: 301-984-7191
Study Sites, Sponsors, Service Providers - CONNECTED! myClin provides a
secure online social collaboration platform for clinical research teams to use
in phase I-IV clinical trials, patient registries and device trials. Use myClin
to conduct site feasibility, share documents, facilitate site initiation, answer
questions, provide training, centralize operational information and communicate with your entire clinical trial community.
Booth: 1926
Contact: Allison Montanaro
Phone: 610-862-0909
Website: www.monitorforhire.com
MonitorForHire.com is a patented Internet-based staffing tool for quickly
connecting pharmaceutical, biotechnology, medical device companies, academic institutions and contract research organizations (CROs) with available
independent clinical trial monitors. Today, the company has a network of
more than 4,000 registered monitors in 60 countries, and nearly 900 clinical
trial sponsors. For more information, please visit www.monitorforhire.com or
call +1-610-862-0909.
Montrium, Inc.
Booth: 2844
Contact: Jeff Shuran
Website: www.montrium.com
Phone: 514-223-9153 Ext. 219
Booth: 1738
Contact: Dorothee S. Fuller
Website: www.moravia.com
Phone: 805-262-0055
Booth: 1317
Contact: Tiffany Wisniewski
Website: www.mortara.com
Phone: 414-354-1600
National Death Index
Booth: 1205
Contact: Michelle Goodier
Website: www.cdc.gov/nchs/ndi.htm
Phone: 301-458-4240
New England Institutional Review
Board
Contact: Carolyn Newman
Website: www.neirb.com
Booth: 1725
Phone: 617-243-3924
New England IRB (NEIRB) is an independent IRB providing ethical review of
research involving human subjects, including phase I - V single and multi/%0!ƫ/01 %!/ċƫƫ+û!./čƫđƫ!2%!3ƫ.+//ƫ+.0$ƫ)!.%ƫđƫ.!!ƫ.+0++(ƫ
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New Orleans Center for Clinical
Research
Contact: John Lacey
Website: www.noccr.com
Moravia Worldwide is an ISO 9001:2009 certified and EN 15038 compliant
global translation services provider that helps you bring your products to
international markets. Established in 1990 and consistently ranking among
the 20 largest language services providers globally, we are life sciences translation experts offering translations in over 120 languages.
Mortara Instrument, Inc.
Phone: 610-233-3304
The National Death Index (NDI) is a central computerized index of death
record information on file in the state vital statistics offices. Working with
these states, NCHS established the NDI as a resource to aid epidemiologists
and other health and medical investigators with their mortality ascertainment
activities.
Montrium is a GxP consulting group focused on providing technological solutions to the life sciences industry. Montrium is unique in that it provides an
integrated set of pre-configured SharePoint based workspaces for records,
quality, systems and clinical process management, as well as consulting
services for systems strategy, implementation and validation. Montrium
Workspaces can be used in our validated SharePoint cloud ‘Montrium
Connect’ or within your existing SharePoint environment.
Moravia
Booth: 1630
Contact: Michael Cohen
Website: www.myoderm.com
Myoderm is a leading service provider for global procurement of commercial
pharmaceuticals including drugs utilized for comparator, rescue, adjunctive
or concomitant therapy. We utilize our experience, knowledge, supplier and
manufacturer network to provide clients with critical information and accurate delivery of product. In addition, Myoderm can act as the Central Rx for
direct to clinical site distribution as an alternative to local site sourcing.
MMG is a global, full-service patient recruitment and retention firm with
offices in the US and UK.
MonitorForHire.com
Myoderm Medical
Booth: 1516
Phone: 865-305-9100
NOCCR / VRG is an academic hospital based research company. We conduct
research in a wide range of medical specialties for the pharmaceutical, biotechnical and device industries. NOCCR Knoxville is primarily a 52 bed Phase
I unit, well suited for conducting first-in-human trials. VRG and NOCCR New
Orleans are primarily focused on conducting later phase studies.
From ECG acquisition at the investigator site to FDA ECG Warehouse development, Mortara has developed a unique platform to help smoothly marshal
a study from site to submission. Mortara’s Rx platform of ECG products was
specifically developed with clinical research in mind. www.mortara.com
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Exhibitor Directory
NextDocs
Booth: 1125
November Research Group
Booth: 1532
Contact: Margaret Mottolo
Website: www.nextdocs.com
Phone: 610-265-9474
Contact: Seth Warhaftig
Website: www.novemberresearch.com
Phone: 415-987-3313
NextDocs is the global leader in providing Microsoft SharePoint-based
compliance and quality management solutions to life sciences organizations.
It enables businesses in regulated industries to achieve compliance with FDA,
EMA and other agencies while automating processes, improving efficiency
and dramatically reducing costs. NextDocs customers include, pharmaceutical companies, biotech firms, device manufacturers and contract research
organizations. Visit us at www.nextdocs.com.
November Research Group is a professional services firm that provides a
complete spectrum of software and services to pharmacovigilance organizations. We have extensive experience in the implementation and production
use of Oracle Argus Safety, Oracle AERS, and ARISg. We are pleased to
announce the availability of PRIMO, our streamlined data capture system for
adverse events, registries, and product complaints, targeted for use by call
centers, safety data mgmt groups, affiliates and partners.
Nextrials, Inc.
Booth: 2007
Novotech
Booth: 2038
Contact: Michael Skinner
Website: www.nextrials.com
Phone: 925-415-8942
Contact: Julia Jones
Website: www.novotech-cro.com/
Phone: +61-285-691-400
Nextrials is an award-winning innovative leader in software solutions for
clinical research. Prism®, Nextrials’ clinical trial management software, brings
together clinical trial management, EDC and EHR integration in a single
package enabling clinical researchers to derive more value from their data,
accelerate time to market and lower costs.
Norwich Clinical Services
Internationally recognized as the leading Australian CRO, Novotech is a full
service clinical CRO with operations in Australia and across the Asia Pacific.
Together with our strategic partners on six continents, we assist biotechnology and pharmaceutical companies bring new products to market by offering a full range of ICH compliant clinical services from first human exposure
through to completion of Phase III trials.
Booth: 2317
Contact: Mitchell Winfree
Phone: 919-889-4414
Website: www.norwichpharma.com/
nSpire Health, Inc.
Booth: 1729
Contact: Michael Brown
Phone: 800-574-7374 Ext. 3231
Norwich Clinical Services is a global CRO that conducts Phase I-III clinical
trials, Phase IV post market surveillance, BA/BE studies, pharmacovigilance, laboratory and analytical services for the pharmaceutical and biotech
industries. NCS offers study management, project coordination for clinical
trial recruitment, and investigator collaboration led by physician teams with
targeted therapeutic experience having completed more than 50 clinical trial
programs and over 2,000 biostudies.
Website: www.nspirehealth.com
nSpire Health offers Centralized Spirometry, Pulmonary Diagnostics,
Challenge Testing, eDiary, and Data Management for Phase I-IV Clinical Trials
including Asthma, COPD, and inhaled therapeutics. We have provided services to over 225 trials in the past 10 years and global support to over 5,000
investigative sites in more than 50 countries. Our quality review team has
reviewed more than 1 million PFT’s. Our experience includes clinical trials as
large as 500 sites spanning 34 countries.
Nova Language Services Ltd.
Booth: 3142
Contact: Arun Mathew
Website: www.nova-transnet.com/
Phone: +44-1908-262-808
Ocasa Logistics Solutions
Booth: 1737
Website: www.ocasa.com
NOVA is a full service translation provider of multilingual language services to
the CRO/Regulatory affairs sectors in Europe. From clinical trial protocols to
marketing authorization dossiers, we will fulfill all your translation requirements with expertise, accuracy and reliability in all European languages.
NOVA is ISO 9001:2008 and UNE EN 15038 certified. Nova has been included
in the top ten translation providers in Southern Europe by Common sense
advisory group.
Novella Clinical
Booth: 2001
Contact: Kristi Robison
Website: www.novellaclinical.com
Phone: 919-484-1921
With over 25 years of experience, OCASA’s Bio-Pharmaceutical logistic
service offers tailor-made solutions for the Pharma industry including export,
import, distribution, fulfillment, & temperature controlled warehousing for:
Diagnostic Specimens, Medication/Vaccines, Experimental Drugs, Controlled
Substances, Dangerous Goods, & Medical Supplies.
Octagon Research Solutions, Inc.
Booth: 3225
Contact: Kristen Casey
Phone: 610-535-6500 Ext. 5751
Website: www.octagonresearch.com
Octagon is the leader in transforming clinical R&D through an integrated
suite of regulatory, clinical, process and technology solutions. Octagon’s
eCTD and CDISC solutions provide the people, process and technology
required to optimize drug development from clinical data collection to regulatory submission.
Novella Clinical, Inc. is a full service contract research organization with dual
headquarters in Research Triangle Park, N.C and Stevenage, England. For
more than a decade, Novella has served as an active partner to the oncology,
biopharma and medical device industries. As the first global eCRO, Novella
integrates deep clinical expertise with industry-leading technologies and
a proven approach to support, streamline and expertly resource the entire
product development process.
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Exhibitor Directory
OMERACT
Booth: 1102
Optum
Contact: Lee Simon
Website: www.omeract.org
Phone: 613-562-5800
Contact: Darrell Ethell
Phone: 905-690-5773
Website: www.optuminsight.com/life-sciences/life-sciences-overview/
Booth: 3325
OMERACT strives to improve endpoint outcome measurement through
a data driven, iterative consensus process involving relevant stakeholder
groups. The term OMERACT was originally established in 1992 to mean
“Outcome Measures in Rheumatoid Arthritis Clinical Trials”. Since then the
OMERACT initiative has turned into an international informal network, with
working groups and gatherings interested in outcome measurement across
the spectrum of rheumatology intervention studies.
OptumInsight is committed to being the global leader in providing consulting, technology, and scientific insights for life sciences companies. Our capabilities deliver the real world evidence you need to successfully commercialize new healthcare technologies, including: strategic regulatory services, late
phase research, clinical informatics, patient reported outcomes, pharmacovigilance, value-based pricing, pharmacoepidemiology, health economics and
outcomes research.
OmniComm Systems, Inc.
Booth: 3301
Oracle Corporation
Contact: Beverly Hudson
Website: www.omnicomm.com
Phone: 630-234-9700
Contact: Peggy Taylor
Phone: 408-595-3077
Website: www.oracle.com/healthsciences
OmniComm provides customer-driven eClinical internet solutions to companies that conduct clinical trial research. We deliver products and services
that ensure ease of use, faster study build, ease of integration, and better
performance. Please visit us at booth 3301 for a demo of our comprehensive
product suite.
Online Business Applications
Booth: 2825
Oracle is a leading strategic software solutions provider to the health sciences industry. Oracle’s comprehensive industry solutions include clinical
trial management/analysis, electronic data capture, adverse event reporting
/ pharmacovigilance, and healthcare interoperability. Oracle partners with
health sciences industry leaders to prevent and cure disease, enhance quality
of life, and accelerate insights for better health.
Booth: 2741
Contact: Emily Aggen
Phone: 630-243-9810 Ext. 223
Website: www.irmsonline.com
Online Business Applications provides advanced software solutions for the
Pharmaceutical, Biotechnology, and Medical Device industries in the areas of
Medical Communications and Drug Safety. We utilize proven leading-edge
technologies, anticipate our clients’ needs, and deliver solutions that exceed
expectations.
OpenClinica
Booth: 2012
Contact: Tia Tep
Website: www.openclinica.com
Phone: 781-547-8410
Booth: 2740
Contact: Dave Mauro
Website: www.openq.com
Phone: 434-466-8078
Booth: 1527
Contact: Thomas Marbury
Website: www.ocrc.net
Phone: 407-240-7878
OCRC is a cutting edge independent Phase I – IV custom-built 35,000 sq. ft.
research site. Designed specifically for Phase 1 clinical trials, OCRC includes
110 in-house volunteer beds, dual lead digital telemetry, CCTV security
system, and cardkey access. A special treatment/observation area has 12
hospital beds (6 used for onsite Hemodialysis studies). OCRC is specialized in
Phase I trials with an emphasis in PK, QTc, and SAD/MAD studies in healthy,
hepatic, hemodialysis, renal populations.
OpenClinica is an open source clinical trials software solution for electronic
data capture and clinical data management. It has been successfully used in
thousands of clinical trials across some very diverse settings in all phases of
clinical trials. OpenClinica offers 2 editions: Community and Enterprise. Visit
us at www.openclinica.com.
OpenQ, Inc.
Orlando Clinical Research Center
Palm Beach CRO
Booth: 1425
Contact: Arthur Simon
Website: www.palmbeachcro.com
Phone: 561-200-3344
Palm Beach CRO provides clinical services that meet the highest quality
standards with appropriate client timelines. PBCRO manages the entire clinical trial process from site selection, investigator meetings, monitoring, IRB,
regulatory affairs, data management, statistical analysis and final reports of
multi-center trials throughout the USA.
OpenQ helps life science companies harness the power of medical networks
to compliantly and efficiently reach influencers and stakeholders. Their
software and data solutions offer commercial and research professionals the
industry-leading support for regulatory compliance needed for these critical,
but high-risk relationships.
Paragon International, Inc.
Booth: 2106
Contact: Christopher Diehl
Website: www.paragonmeetings.com
Phone: 910-772-1599
Paragon International, Inc. has produced successful meetings and events
within the pharmaceutical industry worldwide since 1995, all with “client
satisfaction” guaranteed service. Our in-house travel agent & audio-visual
production services, joined with responsive 24/7 accessibility, highlight
our world-class service and events. Paragon International’s global meeting
production portfolio continues to expand, year after year. We invite you to
discover Paragon’s people & services atBooth #2106.
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Exhibitor Directory
Paragon Solutions
Booth: 1437
PDR Network, LLC
Booth: 2207
Contact: Jamie O’Keefe
Website: www.consultparagon.com
Phone: 610-832-8110
Contact: Thomas Eck
Website: www.PDRNetwork.com
Phone: 201-358-7424
Paragon Solutions is an advisory consulting and systems integration firm
that focuses on Clinical Trial Operations collaboration, document management and information insight and governance. Our mission is to partner with
clients to define and deliver optimal business outcomes through business
process consulting, systems implementation and change management services. Visit our website at www.consultparagon.com.
Booth: 2224
Contact: Heather Puffer
Website: www.PAREXEL.com
Phone: 781-487-9900
PDR Network, LLC is the leading distributor of FDA-approved drug labeling,
safety and REMS information, as well as medication adherence and product
support programs, through Physicians’ Desk Reference® (“PDR”) suite of print
and digital services. PDR Network provides innovative products and services
to deliver industry-leading content across channels, including PDR.net®,
mobilePDR®, R®3D™ and directly through electronic health record platforms.
For more information, visit www.pdrnetwork.com.
Pediatric Pharmacokinetic
Consortium
Booth: 2343
Phone: 816-701-1395
Contact: Jill M Dahlsten
Website: www.ppkc.org/
An innovative leader for 30 years, PAREXEL knows drug development from
end-to-end of the product development cycle: clinical development, integrated technologies, regulatory affairs, market access, and commercialization
services. We complement your capabilities with our global reach, strategic
insight, deep scientific knowledge, and tactical expertise—providing you support and guidance to secure strategic advantage. We provide the precise fit
of expertise when, where and how you need it.
The PPKC is an Academic Site Management Organization developed as a
consortium between four pediatric medical centers. The PPKC offers a “turnkey” platform for the conduct of phase I and II clinical trials over the entire
age spectrum that comprises pediatrics and in the vast majority of pediatric
subspecialty areas.
Patient Recruiters International, Inc. Booth: 2304
Penn Pharma
Booth: 1439
Contact: Larry Risen
Website: www.patientrecruiters.com
Contact: Peggy Rickles
Website: www.pennpharm.com
Phone: 215-862-1273
Phone: 760-448-4823
Patient Recruiters International (PRI) is an innovative patient recruitment
organization that combines powerful direct patient access strategies with
time-tested methods to achieve recruitment objectives. PRI has built confidence and reliability with its innovative tools including targeted direct patient
access, online patient communities, customized social media initiatives, and
risk-shared contracting models.
As one of the longest established pharmaceutical services companies, Penn
Pharma has 30 years of experience in providing integrated drug development, clinical trial supply and manufacturing services to the international
healthcare industry. Penn Pharma is privately owned and operates from
a single site facility in South Wales, UK where we employ over 280 highly
skilled staff.
The Patient Recruiting Agency
Booth: 1944
Booth: 2125
Contact: Lance Nickens
Website: www.patientrecruiting.com/
Phone: 512-789-7788
Contact: Heather Puffer
Website: www.perceptive.com
Phone: 781-487-9900
TPRA’s data-driven IN-HOUSE SOLUTIONS include: creative production,
patient/physician outreach, site selection plus website & call prescreening. Now with RADIUS365™, TPRA’s online platform to track & manage all
response, referral, randomization & retention activities in real-time, TPRA is
the Leader In Successful PATIENT RECRUITING & RETENTION.
Perceptive Informatics®, an industry-leading eClinical solutions provider, combines clinical knowledge and experience with leading technology to decrease
time to market, risk and cost associated with clinical trials. Our portfolio
includes medical imaging, RTSM, EDC, CTMS, ePRO and integration services,
as well as portals, tracking tools and investigator database solutions.
PCM TRIALS
Pharmaceutical Executive
Booth: 1531
Contact: Julie Church-Thomas/Rick Heth Phone: 888-976-2676
Website: www.pcmtrials.com
Booth: 2632
Contact: Anne Young
Website: www.pharmexec.com
Phone: 732-346-3085
PCM TRIALS has been providing clinical trial home visits for all therapeutic
areas and phases of clinical trials since 2008. PCM TRIALS recruits, screens,
hires (does not contract with local home health care agencies) trains and
manages their own unique Certified Mobile Research Nurses (CMRNs) who
understand the critical requirements of mobile clinical research. All CMRNs
are trained in GCP, SOPs, IATA and trial specific protocol. Services available in
the U.S. and abroad.
Pharmaceutical Executive is the only publication that truly covers the
intersection between business and policy. From strategy, to regulation, to
marketing, to the best new ideas about R&D, finance, and IT, Pharmaceutical
Executive covers it all. Pharm Exec offers a plethora of mediums, including
print, digital, online, e-newsletters, and webcasts to name a few.
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Exhibitor Directory
Pharmaceuticals and Medical Devices
Agency (PMDA)
Booth: 1616
Contact: Hiroshi Kato
Website: www.pmda.go.jp
Phone: +81-335-069-456
Booth: 1512
Contact: Stephen Loughrey
Phone: 800-434-5808
Website: www.pharmalinkconsulting.com
Booth: 1533
Contact: Daniel Becker
Website: www.pharmalive.com
Phone: 973-808-1191
Booth: 2213
Business Suite: BS3
Contact: Greg Skalicky
Website: www.pharmanet-i3.com
Phone: 609-951-6623
Booth: 1524
Contact: Lisa Marks
Website: www.pharmaseek.com
Phone: 608-664-9000 Ext. 2222
Booth: 3111
Contact: Meghan Morrissey
Website: www.pharmavigilant.com
Phone: 508-475-4222
PharmaVOICE
Booth: 1308
Contact: Marah Walsh
Website: www.pharmavoice.com
Phone: 215-321-8656
Pharm-Olam International Ltd.
Booth: 2538
Contact: Eric Rupprath
Website: www.pharm-olam.com
Phone: 713-559-7900
Pharm-Olam International delivers full service, quality clinical services to
pharma and biotech sponsors across all therapeutic areas in more than 40
countries. Our access to large patient populations reduces time to market
and overall costs while maximizing sales potential. Since 1994, we have been
committed to our objective: to create value for our clients by satisfying their
clinical development needs with consistent and dependable solutions and
services.
PharmaNet/i3, the inVentiv Health clinical segment, is a leading provider of
global development services to pharmaceutical, biotechnology, generic drug,
and medical device companies, including therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and staffing
from a single clinical professional to an entire functional team. For intelligent
solutions to accelerate development programs of all sizes around the world,
PharmaNet/i3 works for you.
PharmaSeek
PharmaVigilant
PharmaVOICE magazine provides readers with insightful and thoughtprovoking commentary about the challenges and trends impacting the lifesciences industry in a multiple-perspective format through articles covering
a range of issues from molecule through market. PharmaVOICE’s more than
27,000 BPA-qualified subscribers are also kept abreast of the latest trends
and information through additional media resources, including WebLinx
Interactive WebSeminars, Podcasts, Videocasts, and White Papers.
PharmaLive.com is the premier online resource for extensive pharmaceutical industry content. PharmaLive.com provides coverage on pharmaceutical
industry news, events, trends, marketing, sales, research and development
and drugs in the pipeline. Our audience is comprised of pharmaceutical
professionals who rely on our website for their daily industry news and
exclusive industry insight from our editors. For more information, visit www.
pharmalive.com or our sister website, www.pharmalot.com.
PharmaNet/i3
Phone: 919-468-2547
PharmaVigilant is an eClinical company founded to provide broader solutions
to streamline the clinical trial process for biopharmaceutical companies. Its
full suite of SaaS solutions automate the collection, management and analysis of clinical trial data: EDC (InSpire EDC), Data Warehousing (I-Warehouse),
eTMF (I-Vault eTMF), Remote Monitoring (I-Vault rSDV), Study Building
(I-Builder), Automated Site Payments (PaySite), Study Administration
(InSpire Control Center), and Data Entry (I-Monitor).
Pharmalink is the world’s leading Regulatory Affairs Consultancy with
over 400 consultants working at their offices in the USA, UK, India and
Singapore complemented by the Pharmalink Affiliate Network of consultants on the ground in 103 countries worldwide. They provide strategic and
sustainable regulatory affairs consulting and support to clients within the
Pharmaceutical, Biotech, Consumer Health, Medical Device, and Generics
industries.
PharmaLive.com
Booth: 2749
Contact: Tracy Kahn
Website: www.pharma-sys.com
PharmaSys, Inc. is a full service compliance & consulting firm specializing
in FDA regulated industries & offering a wide range of services including
computer validation, audit services, compliance training, commissioning,
equipment/process validation, & QA consulting. Visit us at www.pharma-sys.
com or call (919) 468-2547.
The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese
regulatory agency that reviews applications for marketing approval of
pharmaceuticals and medical devices, monitors product safety, and provides
financial relief to people suffering from adverse drug reactions, in collaboration with the Ministry of Health, Labour and Welfare.
Pharmalink Consulting Inc.
PharmaSys, Inc.
Philips Respironics
Booth: 2433
Contact: John Breeden
Website: clinicaltrials.respironics.com/
Phone: 541-598-3800
Philips Respironics is dedicated to the development of scientifically validated
actigraphy technology specifically for clinical investigation. Our experience
and expertise position us to meet the unique needs of industry sponsors by
integrating our technology with comprehensive service offerings that help
you minimize study burden and risk for your subjects and staff, while providing novel and valuable endpoints.
Since 1995, PharmaSeek, a leading Investigative Site Network representing 250 sites, has partnered with Sponsors and CROs to provide experienced, high-performing investigative sites with clinical trial opportunities.
PharmaSeek-affiliated sites have capabilities in every therapeutic area across
the United States, Puerto Rico, Canada, and the Caribbean.
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Exhibitor Directory
Phlexglobal Limited
Booth: 2842
PRA
Booth: 1113
Contact: Karen Redding
Website: www.phlexglobal.com
Phone: +44-1494-720420
Contact: Tami Klerr-Naivar
Website: www.clearlypra.com
Phone: 610-935-0318
Phlexglobal is a specialist provider of technology enabled TMF document
management solutions & support services, offering a unique combination of
clinical trial knowledge, document management skills, regulatory understanding & technical expertise to deliver clinical research support solutions.
We combine our core services that focus on people provision, document
management & system support to deliver a range of flexible, cost-effective,
targeted & efficient business solutions to our clients.
PHT Corporation
Booth: 2512 & 2513
Contact: Sheila Rocchio
Website: www.phtcorp.com
Phone: 617-973-1600
A leading CRO, PRA is transforming clinical trials through our people,
innovation and transparency. We serve clients across all phases of drug
development in 80+ countries by combining therapeutic and operational
expertise with local knowledge. PRA’s dynamic services and forward-thinking
approach to drug development programs are making a difference to healthcare patients worldwide.
Booth: 1825
Contact: David Cornwell
Website: www.pleasetech.com
Phone: +44-166-682-6540
Booth: 3049
Contact: Fabrice Beauchene
Website: www.popsicube.com
Phone: +33-1-80-90-50-80
Booth: 1828
Contact: Jennifer Palacios
Website: www.ppdi.com
Phone: 877-643-8773
Booth: 1907
Contact: Joanne Emmett
Phone: 215-282-5500
Website: www.premier-research.com
Premier Research is a professional services company providing clinical development services to the pharmaceutical, biotechnology, and medical device
industries. Founded in 1989, the company operates in over 30 countries
worldwide and is a leader in performing clinical research in the analgesia,
oncology, pediatrics, medical device and neurosciences areas. Additionally,
Premier Research provides a strong strategic sourcing group that supports
customers in their resource planning and management.
PrimeVigilance Ltd
Booth: 1931
Contact: Jonathan West
Phone: +44-136-385-399
Website: www.primevigilance.com
PrimeVigilance is dedicated to compliant and cost-effective pharmacovigilance and risk management solutions. PrimeVigilance sits between large
CROs who focus on clinical trail delivery and small service providers who
lack the critical mass, expertise or international presence needed for reliable
scientific and safety services.
POPSI CUBE, the next generation CRO, provides eTrial solutions & services
(e.g. custom EDC, Digital Pen & Paper, iPad/iPhone data capture) as well as
telehealth solutions (remote medical data capture at the patient home) for
Phase I to IV clinical trials. We combine extensive trial management experience with a unique expertise in IT solutions. We are based in France, the USA
and Tunisia. POPSI CUBE, a new way of doing Clinical Research.
PPD
Phone: 704-997-5096
PleaseTech specializes in document review and authoring solutions designed
to transform the key process of producing quality documents. Our products
enable Word and other document types to be created, co-authored and
reviewed in a collaborative, controlled, secure environment. From component-based authoring and content reuse to document co-authoring and
review, companies gain a valuable process enhancement saving time and
money whilst users have access to extensive, easy-to-use functionality.
POPSICUBE
Booth: 2531
Contact: Robert Loll
Website: www.gopraxis.com
Praxis has been providing the world’s leading pharmaceutical and biotech
companies with focused patient recruitment for clinical trials since 2001.
Services include patient profiling, recruitment planning, centralized fulfillment, media relations, digital strategy, advertising and program management. Visit www.gopraxis.com to learn more.
PHT Corporation is the largest, most experienced, and innovative provider
of systems used to collect clinical outcome data from study participants.
The PHT System includes scientific and regulatory expertise which enables
biopharmaceutical companies and CROs to reduce trial timelines, improve
participant safety and leverage technology to serve good science. Sponsors
using PHT Systems have achieved at least 18 regulatory submissions and 16
approvals resulting in 14 PRO-based label claims.
PleaseTech Ltd.
Praxis
PRL Central Laboratory Services
Booth: 1644
Contact: Scot Stubenhofer
Website: www.prlwecare.com
Phone: 913-339-0489
PRL Central Laboratory Services is one of the best kept secrets in the business. We specialize in comprehensive diagnostic testing, with a focus on
protocol requirements. We serve all phases of clinical research on a global
basis, providing each client with accurate study set-up, timely results delivery
and validated data management.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. With offices in 45
countries and more than 11,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help
clients and partners accelerate the delivery of safe and effective therapeutics
and maximize the returns on their R&D investments.
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Exhibitor Directory
Projecis, Inc.
Booth: 1638
QPS LLC
Booth: 2948
Contact: Russell Holmes
Website: www.projecis.com
Phone: 855-776-5324
Contact: Lily Rosa
Website: www.qps.com
Phone: 512-350-2827
Projecis is a cloud-based platform that enables project stakeholders – sponsors, sites, CROs – to connect teams, organize data, and share information for
better trial outcomes. Users access project status, costs, files, profiles (including LinkedIn®), video updates via secure site. Team collaboration is further
cultivated through the integration of Skype®, IM/chat, email, text, phone, etc.
FREE trial available!
PROSAR
Founded in 1995, QPS is a GCP/GLP-compliant CRO supporting drug discovery and preclinical and clinical drug development. QPS provides quality
services to our pharmaceutical and biotechnology clients worldwide. Our
linearly integrated core competencies include DMPK, Toxicology, Bioanalysis,
Translational Medicine, Early Stage and Phase II – IV Clinical Research at our
research sites in Newark, DE; Springfield, MO; Groningen, The Netherlands;
Hyderabad, India; and Taipei, Taiwan.
Booth: 2428
Contact: Mike Bieniek
Phone: 651-917-6116
E-mail: Email: [email protected]
Website: www.prosarsafety.com
PROSAR is a leading provider of pharmacovigilance and medical information services to the pharmaceutical and biopharmaceutical industries. Our
24/7 drug safety call center is staffed 24/7 by healthcare professionals that
provide adverse event intake and processing, medical information services
and product complaint services.
Prosoft Clinical
Booth: 3307
Contact: Ayala Rom
Website: www.prosoftclinical.com
Phone: 215-704-3344
Booth: 2509
Contact: Jason Bertram
Website: www.qc2.com
Phone: 424-208-3340
QC2 provides worldwide audit and consulting services, including: GCP,
GLP, and cGMP Audits; Bioanalytical Laboratory Audits; Clinical Pathology
Laboratory Audits; Sponsor, CRO, and Vendor Audits; Computerized System
Validation Audits; Standard Operating Procedures Review and Preparation;
GCP, GLP, QA, and SOP Training; and Consulting.
Quality Associates, Inc.
ProTrials Research, Inc.
Booth: 2612
Contact: Wendy Powers
Website: www.protrials.com
Phone: 650-864-9180
Booth: 2639
Contact: Paul Swidersky
Phone: 410-884-9100
Website: www.qualityassociatesinc.com
Prosoft Clinical is a Pharmaceutical Product Design and Development
Organization with CRO capabilities. Since 1995, Prosoft Clinical has been providing services to the Pharmaceutical, Biotech, and Medical Device industries.
Spanning all areas of drug development including pre-clinical and clinical
phases I-IV, Prosoft Clinical can help expedite your clinical trial needs including Regulatory and Clinical Operations, Biostatistics, and Data Management.
Quality Associates, Inc. was established in 1986 as an independent third party
QA consulting company initially specializing in GLPs and branching into GCPs
in the early 2000s. Capabilities include all aspects of GCP and GLP QA work;
e.g., site qualification and study audits; data, database and master file audits;
bio-analytical audits; training; computer system validation audits, etc. QAI
has a staff of 15 auditors, all with various scientific experience.
At ProTrials, we provide pharmaceutical, biotechnology, and medical device
companies the ability to move a new drug or device from conception to FDA
approval. Throughout our 16 years we’ve steadily grown and added employees each year to our team. We’re small enough to be flexible and deliver the
personal attention you deserve. Large enough to access resources worldwide. Our clients hire us because of our senior level staff and our excellent
employee retention rate. Experienced, trusted partners.
PRUDENTAS LLC
Quality and Compliance
Consulting, Inc.
Quanticate, Inc.
Booth: 2643
Contact: James Brown
Website: www.quanticate.com
Phone: 857-998-6843
Quanticate strives to help our clients maximize the value of their clinical data.
Quanticate offers an extensive suite of Biometric Solutions that standardize the collection, analysis, and reporting of clinical trial data. As the largest
fully dedicated clinical biometrics company we utilize top industry talent
and leading technology to ensure our customers bring their drugs to market
more quickly than ever before.
Booth: 2843
Contact: Ekaterina Nikolaevskaya
Phone: +7-495-628-3802
Website: www.prudentas.com
PRUDENTAS is a CRO organizing Phase Ib — IV clinical trials in all therapeutic
areas in Russia with fast recruitment and high quality. We would be happy
to offer services of our highly experienced clinical research professionals to
accelerate the clinical development of your compounds.
Queensland Clinical Trials Network
Booth: 2301
Contact: Mario Pennisi
Website: www.qctn.com.au
Phone: +61-7-3331-3955
QCTN is the primary point of contact for domestic and international organizations seeking to undertake preclinical and clinical research in Australia.
QCTN’s aim is to promote and raise the visibility of the Australian biopharmaceutical industry and life sciences service providers at a national and international level and to support them in building their capabilities and marketing
activities. Accompanying members include: Clinical Network Services, The
Wesley Research Institute and Q-Pharm.
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Exhibitor Directory
Quest Diagnostics Clinical Trials
Booth: 1518
Real Staffing Group
Contact: Florence McEvoy
Phone: 800-209-9816
Website: www.questdiagnostics.com/home/companies/clinical-trials.html
Quest Diagnostics Clinical Trials provides laboratory solutions by harnessing the power of the entire Quest Diagnostics organization, including
unsurpassed global central laboratory and biomarker services, diagnostics
& esoteric testing, and research & development innovation, combined with
one of the world’s largest clinical laboratory, a single global database, and
unparalleled scientific and logistics expertise.
Quintiles
Booth: 1401
Contact: Sandra Woodlief
Website: www.quintiles.com
Phone: 866-267-4479
Real Staffing Group’s pharma and biotech division delivers local and global
talent across the life sciences industry. We value the strong relationships we
build with both our clients and candidates which enable us to work with leading organizations and offer only the most desirable career opportunities.
Booth: 1143
Contact: Brittany Thomez
Website: www.qumas.com
Phone: 603-957-4878
Booth: 1624
Contact: Business Development
Website: www.quorumreview.com
Phone: 206-448-4082
Phone: 215-441-6493
REGISTRAT-MAPI
Booth: 2441
Contact: Amy Wynn
Website: www.registratmpapi.com
Phone: 215-568-0121 Ext. 110
Regxia Inc.
Booth: 1545
Contact: Betty Cory
Website: www.regxia.com
Phone: 416-620-5236 Ext. 233
Regxia is a unique scientific and regulatory consulting firm servicing the
pharmaceutical and biotech industries. With a primary focus of collaborating with our customers, we provide knowledge, experience and innovation.
Regxia’s newest service - e-architec provides an electronic regulatory solution that evolves with your needs!
Research Across America
Quorum Review is an independent ethics review board that is fully accredited by the Association for the Accreditation of Human Research Protection
Programs (AAHRPP). Our primary focus is to safeguard the rights and wellbeing of research participants. We provide sponsors, CROs, institutions, and
sites with reliable, responsive service that ensures efficient study start-up and
management.
Randstad Pharma
Booth: 2751
Contact: Dan Henrich
Website: www.ReedTech.com
REGISTRAT-MAPI is the industry’s only clinical research organization dedicated exclusively to “real-world” clinical research. We provide strategic and
operational expertise as well as services in the design and conduct of late
phase studies.
QUMAS is the leader in Compliance and Quality Management Solutions for
the Life Sciences industry, with more than 260 global customer deployments
and domain expertise in regulatory compliance since 1994. The QUMAS
Compliance Platform combines document and process control, regulatory
submissions, training and collaboration capabilities in one central system.
QUMAS Quality Management solutions provide Electronic Document
Management, Electronic Process Management and GMP Compliance
Management.
Quorum Review IRB
Reed Technology
Providing SPL conversions and e-submissions, SPL XML composition and
printing services for print- and web-ready promotional materials, content
lifecycle management, PLR and labeling consulting, xEVMPD Solutions, drug
label databases - PDR3D (Human) and LabelDataPlus (Animal), digitization,
indexing, database creation, and web archiving services.
Quintiles is the only fully integrated biopharmaceutical services company
offering clinical, commercial, consulting and capital solutions worldwide.
The Quintiles network of more than 25,000 engaged professionals in 60
countries works with an unwavering commitment to patients, safety, and
ethics. Quintiles helps biopharmaceutical companies navigate risk and seize
opportunities in an environment where change is constant.
QUMAS
Booth: 1431
Contact: Ben Sparks
Phone: 617-874-7859
Website: www.realstaffing.com/en/page/pharma_sector/
Booth: 2616
Contact: Kelly Walker
Phone: 972-241-1222 Ext. 207
Website: www.researchacrossamerica.com
Research Across America is an Independent Site Network-ISN (Non-SMO)
that manages and conducts Phase I thru Phase IV and Post marketing trials
utilizing their 7 regional multi-specialty sites located in Dallas, TX, El Paso,
TX, Houston TX, Suburban Houston-Katy, TX, New York, NY, Santa Ana, CA,
Reading/Lancaster, PA, and most having Satellite Sites in their surrounding
areas. The physicians affiliated with Research Across America have conducted over 1800 clinical trials since 1989.
Booth: 1207
Contact: Kimberlee Hodges
Phone: 877-335-8210
Website: www.randstadpharma.com
Randstad Pharma matches professionals with career opportunities at the
world’s leading biopharma and life science companies for more than 20
years. Our candidates are matched at organizations that will fully utilize
their expertise while advancing the candidates skills and career aspirations. Our staffing services encompass specific areas of Clinical Research
& Development, including Clinical Operations, Pharmacovigilance, Medical
Writing, Clinical IT, Biometrics, Regulatory Affairs and more.
ResearchPoint Global
Booth: 1943
Contact: Tracy Dugan
Website: www.researchpointglobal.com
Phone: 512-343-1092
ResearchPoint Global is a full-service CRO providing drug, device and
biologic development services worldwide. With expertise spanning all major
therapeutic areas, ResearchPoint Global delivers a unique blend of experience combined with the creativity, responsiveness, and customer focus of a
highly nimble organization.
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Exhibitor Directory
ReSolution Latin America
Booth: 2444
Rx Trials Inc.
Booth: 1632
Contact: Eric Johansson, Ph.D.
Phone: +54-114-773-2401
Website: www.resolutioncrs.com/
Contact: Anne-Marie Baughn, RN MSN
Phone: 410-465-2455 Ext. 103
Website: www.rxtrialsinc.com
ReSolution Latin America is a CRO/clinical consultancy company completely
focused on clinical development in Latin America and we specialize in providing clinical research solutions for development companies that are interested
in Latin America for their clinical development programs. We provide the
opportunity to work with a credible regional niche CRO provider that is able
to successfully deliver clinical research conducted in Latin America to international quality standards and expectations.
RxTrials is an elite Investigative Site Network comprised of private physician
practices, clinics, and hospitals. Since1994, our inpatient and outpatient sites
have successfully completed over 1,000 clinical research studies with more
than 100 Sponsors and CRO’s. We set the standard for quality in study coordination and site management services.
Rho, Inc.
Booth: 3100
Contact: Kathleen Brooks
Website: www.rhoworld.com
Phone: 919-408-8000
Booth: 2225
Contact: Sean Quinn
Website: www.rpsweb.com/
Phone: 215-540-0700
RPS, The Next Generation CRO, provides comprehensive global Phase I-IV
clinical development solutions to the Pharmaceutical, Biotechnology, Medical
Device and Diagnostic industries. By combining an experienced clinical
research operations infrastructure with the industry’s largest resourcing
engines, RPS is uniquely positioned to offer our Customers a broad spectrum
of outsourcing solutions. With more than 4,000 employees, RPS operates in
64 countries across the globe.
RSD, Inc.
Booth: 1741
Contact: Nicole Lindenbaum
Website: www.rsd.com/
Phone: 201-996-1000
Booth: 2845
Contact: Graham Dyck
Website: www.rtihs.org
Phone: 919-316-3788
Booth: 1013
Contact: Kristen Maronek
Website: www.rwd.com
Phone: 918-899-7074
SAGE
Booth: 1826
Contact: Lisa LaMont
Website: www.sagepub.com
Phone: 805-410-7239
SAS Institute Inc.
Booth: 1625
Contact: Janet Forbes
Website: www.sas.com/dia12
Phone: 919-677-8000
As the leader in business analytics software, SAS helps the life sciences
industry analyze clinical, research and business data. One-hundred percent of
biopharmaceutical companies on the Fortune Global 500® chose SAS® as the
industry standard for moving better therapies to market faster. Since 1976,
SAS gives users THE POWER TO KNOW®.
Scarritt Group, Inc.
Booth: 3013
Contact: Tracy Torrez
Website: www.scarrittgroup.com
Phone: 520-262-8020
Scarritt Group, Inc. is a privately owned logistics company founded in 1999
and headquartered in Tucson, Arizona. Our depth and range of experience collectively spans over 100 years in hotel and logistics management.
We believe successful meetings don’t just happen. You need a partner that
understands your goals and a company that is flexible enough to deliver the
personalized·service you require. We have experience, expertise and proven
performance to exceed your expectations
RTI Health Solutions (RTI-HS) provides consulting and research expertise to
help pharmaceutical, biotechnology, diagnostics and medical device companies develop and commercialize their products.
RWD, A Division of GP Strategies
Phone: 949-228-1430
SAGE is a leading international publisher of journals, books, and electronic
media for academic, educational, and professional markets. Since 1965, SAGE
has helped educate a global community spanning a wide range of subject
areas including business, humanities, social sciences, and science, technology,
and medicine. Visit us at www.sagepub.com.
RSD is the leading provider of information governance (IG) solutions for the
enterprise. Using RSD GLASS, companies create corporate policies that are
actively enforced across organizational and jurisdictional boundaries, IT systems, content repositories, and paper archives. RSD solutions help companies
reduce operating costs and risk exposure through robust information governance programs that span multiple jurisdictions and decades-long lifecycles.
Booth: 1312
Contact: Shalini Modi
Website: www.rxlogix.com
RxLogix is the foremost provider of business and technology services for
Drug Safety and Pharmacovigilance. Our experienced team of experts offer
consulting and strategic software solutions. We bring best practices across all
areas of drug safety. RxLogix Solutions have been developed by the leading
experts on the Oracle Argus Safety suite and Drug Safety.
Rho is a full service CRO dedicated to enhancing the quality and speed of its
customers’ clinical trials through the highest levels of performance, accuracy,
and scientific integrity. Rho contributes to the success of pharmaceutical,
medical device, and biotechnology studies in a range of therapeutic areas.
RPS, Inc.
RxLogix Corporation
RWD’s focus is to assist its clients operationalize their business strategies
and transform their knowledge workers. In the pharmaceutical industry,
RWD’s infoMaestro™ solution enables rapid access and delivery of Regulated
or Time-Sensitive Information across an enterprise. Employees can better
author, manage, and distribute information.
Schlafender Hase GmbH
Booth: 1938
Contact: Frank Hessler
Website: www.text-verification.com
Phone: 973 685-6123
The Text Verification Tool (TVT) developed by Schlafender Hase GmbH is
the global standard solution in computer-driven proofreading. It helps global
pharmaceutical leaders save time, money, improve quality, avoid embarrassment and legal costs that can result from avoidable mistakes. Designed to
support all standard file types, including XML.
182
Exhibitor Directory
Schulman Associates IRB
Booth: 3000
Contact: Michael Loughry
Website: www.sairb.com
Phone: 513-761-4100
Sino-American Pharmaceutical
Professionals Association (SAPA)
Contact: Mabel Ju
Website: www.sapa-gp.org/
Schulman Associates IRB has been a leading provider of review services in
the US and Canada since 1983. Schulman is AAHRPP accredited and has an
unparalleled FDA audit history. In 2011, Schulman acquired Independent IRB,
an industry leader in Phase I review service, allowing both organizations to
provide a more comprehensive suite of review services. With our industryleading suite of etools and reputation for quality, we’ve helped define the
expectations. Now we’re redefining the experience.
SDL
Booth: 1443
Contact: Liz Grotzke
Website: www.sdl.com
Phone: 781-464-6249
Booth: 1343
Contact: Michael O’Gorman
Website: www.sentrx.com
Phone: 973-826-1881
Booth: 1313
Contact: Ronald Baker
Website: www.sgs.com/cro
Phone: 877-677-2667
Booth: 2303
Contact: Bob Macadangdang
Website: www.sharpcorporation.com
Phone: 484-269-8381
Booth: 3231
Contact: Chelsea Gerhart
Website: www.sitrof.com
Phone: 609-897-9180 Ext. 108
Small Planet Meetings
Booth: 2637
Contact: Sarah Dye
Phone: 800-479-1637
Website: www.smallplanetevents.com
Event management services company delivering investigator meetings, advisory boards and KOL meetings. We’re focused on pharma; we understand
the terminology and the factors driving industry conversations –building
physician relationships, patient recruitment, regulatory compliance, and value
for money.Our intention is to turn your cost into an investment; helping you
to build event programmes, which engage and enthuse your audience, and
create physician advocacy for your clinical programmes.
SNBL Clinical Pharmacology Center Booth: 1144
Contact: Felipe Troncoso
Website: www.snbl-cpc.com
Phone: 410-706-8894
SNBL-CPC is a 96 bed full service Clinical Pharmacology Research facility
based in Baltimore, Maryland. Our team is focused on performing high complexity early phase clinical research programs. We conduct clinical trials for
multiple segments of clients, including, pharmaceutical, biotech, academic,
and government. In addition, SNBL-CPC offers all ancillary trial support
services such as protocol consulting and design, data management, etc. for
early phase I-IIa studies.
SGS Life Science Services has 35 years of experience as a global contract
service organization providing integrated solutions from preclinical activities to Phase I-IV clinical trials, bioanalytical and QC testing. Our clinical
research services include clinical pharmacology trials, late phase monitoring
& management, biometrics and pharmacovigilance. With more than 1,300
employees and 2,000 clinical trials performed, SGS serves the pharmaceutical, biotechnology and medical device industries.
Sharp Corporation
Sitrof Technologies, Inc.
Sitrof provides premier IT and document management solutions that enable
top Life Sciences companies to improve efficiency and mitigate risk. Backed
by decades of industry knowledge and world-class partnerships, the process
harmonization, collaboration and compliance experts at Sitrof have saved
millions of dollars and countless time for hundreds of leading firms.
Sentrx, a leading provider of technology-enabled solutions and services for
global drug safety, aims to help pharmaceutical, biotechnology, medical
device, and consumer health companies document the safety profile of their
products during clinical development and post-approval, enabling them to
minimize risks & maximize benefits. Sentrx delivers a unique combination
of highly skilled medical experts, exclusive technology, and best practices in
drug safety monitoring. For info. call 972-826-1881.
SGS
Phone: 215-652-8141
Founded in 2002 as a non-profit organization, SAPA –Greater Philadelphia
(SAPA-GP) is one of the most active and reputable professional organizations
in the US and China. SAPA-GP has thrived in the Greater Philadelphia (GP)
area, one of the major homes for the world pharmaceutical industry.
SDL enables global businesses to engage with their customers in the
language, the media and at the moment they choose. We help businesses
manage their brands, drive global revenues, accelerate speed to market and
enrich their customers’ experience. SDL solutions drive global reach across
multiple languages, cultures, channels and media. SDL has over 1,500 enterprise customers, 400 partners and a global infrastructure of 70 offices in 38
countries.
Sentrx
Booth: 1104
SNM Clinical Trials Network
Booth: 2849
Contact: Catherine Michaels
Website: www.snm.org/ctn
Phone: 703-708-9000
The Clinical Trial Network’s mission is to help facilitate the effective use of
molecular imaging biomarkers in clinical trials. We provide tools to promote
faster, more cost-effective drug development. Tools include a registry of
qualified molecular imaging sites and biomarker manufacturers, a scanner
validation program, access to standardized molecular imaging protocols and
site personnel education.
Sharp, a United Drug Company is a world class healthcare contract packager
serving the Rx, OTC, nutritional, animal health, clinical trials and biotechnology markets. We offer full range of design services and are recognized for
delivering reliable, cost-effective packaging solutions in blister packaging,
bottling, carded blisters, vial labeling, pouching and more. Our dedicated
project management teams serve customers from concept to completion.
183
Exhibitor Directory
Soltex Consulting LLP
Booth: 3114
Spectra Clinical Research
Contact: Christie Mahoney
Website: www.soltexconsulting.com
Phone: 609-955-3516
Contact: Charles Keyes
Phone: 203-855-1813
Website: www.spectraclinicalresearch.com
Booth: 2533
Soltex Consulting advises our clients on driving efficiencies throughout the
clinical trial lifecycle. Soltex employs an innovative framework to analyze
business problems-examining them through the lens of People, Processes
and Technology. We then recommend value-driven strategies and implement
solutions to tackle our clients’ most critical issues.
As a global provider of central laboratory services, Spectra Clinical
Research pairs the capacity and technology of a large corporation with
the flexibility and responsiveness of a small specialty laboratory to support
diverse clinical trials of all sizes. We focus on meeting your unique research
needs and delivering timely, reliable results.
Sonic Clinical Trials
Booth: 1844
SpringFire Lab Network
Booth: 1349
Contact: Paullette Azar-Tannous
Website: www.sonicclinicaltrials.com.au
Phone: +61-298-556-006
Contact: James McClintic
Email: info@springfirelabs.com
Website: www.springfirelabs.com
Phone: 888-424-3977
Sonic Clinical Trials is a wholly owned subsidiary of Sonic Healthcare Limited;
one of the world’s largest medical diagnostic companies. Sonic Clinical Trials
is a dedicated central laboratory supporting all phases of clinical trials and
ensuring the highest regulatory compliance. All studies are managed locally
whilst following best global practices. Services Offered: Central Laboratory
Services: Protocol Management, Data Management, Blood Collection,
Logistics and Laboratory Services.
SpringFire Laboratory Network is a group of hand-selected “high science”
laboratory and diagnostic centers of excellence offering over 1000 specialized tests with experience in more than 320 trials. The SpringFire affiliated
laboratories are highly regarded in their specialized areas of testing expertise
and are ready to work with you to provide an outstanding laboratory experience. Let SpringFire Laboratory Network meet the unique testing needs of
your next clinical trial research project.
Southern Star Research
Statistics and Data Corporation (SDC)
Booth: 1818
Booth: 2005
Contact: David Lloyd
Phone: +61-290-116-266
Website: www.SouthernStarResearch.com
Contact: Jim Townsend
Website: www.sdcclinical.com
Phone: 480-632-5468
Southern Star Research is a leading Australian CRO, dedicated to providing an outstanding quality of personalised service. Expertise covers Ph I-IV
trials in Pharmaceutical, Medical Device & Biotechnology projects. Services
incl; Project Management, Monitoring, In-house staff placement, Patient
Recruitment, Local safety reporting, Medical Monitoring & local study sponsorship. Staff are located across Australia & New Zealand, with a focus on
providing high quality & cost effective services.
SDC is a provider of data management, EDC, and biostatistics services that
focuses on personalized service and premier quality execution. Since 2005,
SDC has successfully supported over 100 clinical trials ranging from early
phase studies to large pivotal trials. SDC has built a reputation with our
clients for delivering the highest quality output on every study we support
while meeting or exceeding the project timeline expectations.
Sterling Institutional Review Board Booth: 2414
Sparta Systems
Booth: 1037
Contact: Sales
Website: www.spartasystems.com
Phone: 732-203-0400
Contact: Kathye Richards
Website: www.sterlingirb.com
Sterling Institutional Review Board is a fully accredited IRB committed to
the protection of human research subjects. Established in 1991 and located
in Atlanta, Georgia, Sterling IRB reviews research studies conducted in the
United States, Canada, Mexico, and Puerto Rico. Our staff provides an outstanding level of customer service.
Ensure the trust, safety and efficiency of your products and services to
Sparta Systems. Founded in 1994, Sparta Systems maintains an extensive
customer base in pharmaceuticals, medical devices, biotechnology, CROs,
CPG, electronics manufacturing and other highly regulated industries. The
company’s flagship product is TrackWise EQMS - used by quality, manufacturing and regulatory affairs professionals to manage quality control and
compliance issues across the enterprise.
Spaulding Clinical Research
Phone: 770-690-9491
Booth: 3117
Contact: Kathy Forde
Phone: 262-334-6020
Website: www.spauldingclinical.com
Stiris Research Inc.
Booth: 2032
Contact: Robert Soto
Website: www.stirisresearch.com
Phone: 773-633-3424
Stiris Research is an entrepreneurial Clinical Trial Management Company,
providing comprehensive study management solutions for Phase I through
Phase IV clinical research. Our expertise provides tailor-made solutions for
challenging protocols executed across North America. Every team member
we put forth in a proposal guarantees you two things; An entrepreneurial
mindset to owning your study, Commitment to work the project until the end
– two reasons we’ve never missed a data lock.
Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides
Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a
medical device manufacturer. Visit us in booth 3117 to learn how our fully
integrated, paperless Phase I EDC solution and the proprietary Spaulding iQ
Electrocardiograph for Core ECG Services redefines efficiency and optimizes
study quality. See our live demonstration of the Spaulding iQ mobile application and discuss your next study with our experts.
184
Summit Global Health
Booth: 3350
Contact: Tiffany Kleefeld
Phone: 860-598-9868
Exhibitor Directory
Swiftwater Group
Booth: 1716
Synteract
Booth: 1925
Contact: Tom Fritz
Website: www.swiftwater.com
Phone: 520-603-2650
Contact: Trisha Vonder Reith
Website: www.synteract.com
Phone: 760-268-8028
Swiftwater Group provides Integrated Drug Development Consulting services to pharmaceutical and biotechnology companies. Our services cover
the functional areas of Regulatory Affairs; Chemistry, Manufacturing, and
Controls (CMC); Clinical and Nonclinical Management; and Quality Assurance
support. Swiftwater Group understands the complexities of the global
regulatory landscape (US/EU/Japan), and deploys consultants with focused
expertise to ensure the development process runs smoothly.
Synteract is a full-service CRO with a 17-year track record supporting clients
in all phases of clinical development, across all major therapeutic areas. With
its “Shared Work-Shared Vision” philosophy Synteract provides customized
Phase I-IV services collaboratively and cost effectively ensuring on-time
delivery of quality data so clients get to decision points faster. Headquartered
in California, with offices in North Carolina and the Czech Republic, Synteract
delivers trials internationally.
Sylogent
Booth: 2102
TAKE Solutions
Contact: Jack Yeager
Website: www.sylogent.com
Phone: 215-504-7000
Contact: Mike Lewis
Phone: 609-720-1002 Ext. 230
Sylogent delivers affordable technology solutions that are guaranteed to
save your company millions of dollars through better compliance, improved
efficiencies and lower operating costs. Contact us today to see how our solutions can help your company. Clinical Study Management. Electronic Data
Capture. Protocol Registration. Patient Recruiting. Clinical Data Disclosure.
Publication Planning. Speaker Bureau Management. Speaker Payment
Reporting.
Symbio, LLC
Website: www.takesolutions.com
TAKE is a global business & technology solutions company with domain
excellence in Life Sciences & offers IP-based software and extensive
knowledge-based solutions to enable efficient clinical, regulatory, safety and
commercialization processes. TAKE has been recognized as a leader by IDC’s
MarketScape Worldwide Life Sciences R&D IT Outsourcing for 2011. Present in
8 countries TAKE is CMMI Level 5, PCMM Level 3 certified. 150+ Fortune-1000
customers. Gold Partners of Microsoft, Oracle & SAP BO.
Booth: 3043
Contact: Betsey Zbyszynski
Phone: 619-955-8926
Website: www.symbioresearch.com
Symbio is a full-service CRO. Since 2002, we have been successfully managing Phase I-IV clinical trials. By partnering with our Sponsors, we are involved
with strategic planning throughout the entire product development cycle.
Therapeutic areas include dermatology, ophthalmology, women’s health and
internal medicine.
Synchrogenix Information Strategies, Inc.
Contact: Lauren Sobocinski
Website: www.synchrogenix.com
Contact: Sam Stein
Website: www.synowledge.com
Target Health Inc.
Booth: 2542
Contact: Warren Pearlson
Website: www.targethealth.com
Phone: 212-681-2100
Target Health Inc. is a New York City-based eCRO with staff dedicated
to all aspects of Regulatory Affairs and Strategic Planning, Chemistry
Manufacturing and Controls, Clinical Research, Biostatistics, Data
Management and Medical Writing. Target Health has developed innovative
web-based software that provides a transparent paperless environment and
significant productivity edge.
Booth: 3329
Phone: 302-892-4800
For over 25 years Synchrogenix has been providing regulatory writing
support to the pharmaceutical, biotech, diagnostic, and medical device
industries. All of our 40+ in-house writers and editors are located in one of
our 8 locations worldwide. With experience in a range of therapeutic areas,
functions, and document types, Synchrogenix can provide consistent support
from pre-IND through post-submission.
Synowledge Drug Safety and
Regulatory Affairs Services
Booth: 2239
Tarius A/S
Booth: 1636
Contact: Nina Lindholst
Website: www.tarius.com
Phone: 45-721-121-24
Tarius Global Regulatory Intelligence Our customer-specific web portal consolidates your choice of Medical Device, Human Drugs & Biologics information from 75+ countries. Get ready access to local knowledge on clinical trials,
submissions, GMP, adverse event reporting, pricing & reimbursement, and
much more. National regulations and guidances provided with bibliographical
data in English. All in one searchable interface with “Google-like” functionality, updated daily, unlimited access worldwide.
Booth: 2100
Phone: 203-504-2561
Synowledge is a leading global provider of drug safety, regulatory affairs and
related IT solutions to small, mid and large sized pharmaceutical, biotechnology and medical device companies. Our experts come with years of experience developing innovative and highly-customizable solutions for drug safety
and regulatory affairs management. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to
meet our clients’ needs.
Tata Consultancy Services
Booth: 1713
Contact: Mark Sekula
Website: www.tcs.com
Phone: 732-476-8857
TCS has more than 1500 associates in India, US & Hungary working on
the Drug Development Programs of 9 Global Top 20 Pharma Companies
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Data Management: More than 650 associates working for 5 of the top 20
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185
Exhibitor Directory
Technical Language Services, Inc.
Booth: 2412
Therapak Corporation
Contact: Karen B. Leyton
Website: www.tls-translations.com
Phone: 205-507-8774
Contact: Arbi Harootoonian
Phone: 626-357-5900 Ext. 254
TLS is a full-service supplier of translation, interpretation, and transcription
services in more than 150 languages. We specialize in the pharmaceutical and
medical device industries. Look to TLS for excellent quality, price, customer
service, and turnaround. 24/7 availability and global offices. ISO 9001-2008
certified.
Technical Resources International, Inc.
Contact: Jill Meritt
Website: www.tech-res.com
Website: www.therapak.com/
Therapak provides 3rd party kit assembly and logistics solutions to pharmaceutical and laboratory organizations. Therapak’s menu of services include
assembly of lab convenience kits for collection of samples, temperature
sensitive shipping systems, requisition and label printing and ancillary supply distribution direct to sites on a global basis. Therapak’s global presence
allows local solutions for global trial support from our facilities in the US, UK
and Singapore.
Booth: 2340
Phone: 301-897-1774
Therapeutics Inc.
Booth: 1731
Contact: Silvio Severini
Website: www.techorizon.com
Phone: +39-045-822-2811
Therapeutics, Inc. is The Dermatology CRO(TM) with unparalleled dermatology expertise & decades of experience; a full service CRO with numerous
product approvals. TI helps clients with strategy, clinical development & life
cycle management: concept, design, project planning & management, regulatory review & registration. TI designs and executes Ph I –IV multicenter trials
in acne, psoriasis, dermatitis, rosacea, alopecia, tissue fillers, inflammation &
all pediatric/adult dermatology categories.
Techorizon are technology experts supplying the biopharmaceutical and
medical device industries with advanced solutions and services. As a subsidiary of CROMSOURCE, an International CRO, Techorizon combines technical
expertise with a deep understanding of clinical research processes to deliver
innovative and customized technology solutions which seamlessly integrate
to support all aspects of clinical development.
TFDA/Center for Drug Evaluation,
Taiwan
Contact: Frank Liu
Website: www.cde.org.tw
TheraSim
Booth: 3148
Contact: Scott Harris
Website: www.TheraSim.com
Phone: 919-226-0608
TheraSim provides clinical trial protocol training on a web-based virtual
simulation platform that is accessible anywhere, anytime, and on any device.
Since 2004, TheraSim has been improving clinical outcomes through online
simulation that provides a safe environment to access, practice and remediate competencies necessary to achieve desired outcomes. Our simulator
can catch protocol errors before they occur saving clients time and money
implementing of clinical trials.
Booth: 1618
Phone: +886-2-81706000
Thomson Reuters
Booth: 3144
Contact: Shawn Clary
Website: www.theoremclinical.com/
Phone: 484-689-2628
Booth: 3001
Contact: Thomson Reuters
Phone: 215-386-0100
Website: science.thomsonreuters.com/pharma
Taiwan Food and Drug Administration (TFDA) and, Center for Drug
Evaluation regulatory agencies, review investigational new drug, new drug
application, generic drug applications, bridging study evaluation, drug master file, BA/BE protocol and reports, dissolution reports, IDE, investigational
device exemption, pre-market approval, evaluate PMA, and provide health
technology assessment, consultation and regulatory science on the regulation of medicinal products.
Theorem Clinical Research
Booth: 1208
Contact: Chuck Holland
Phone: 858-571-1800
Website: www.therapeuticsinc.com/about_us
TRI is a full service CRO with particular expertise in infectious diseases,
oncology, infertility, and drug abuse. Our 32 years’ experience as a functional service provider sets us apart: we manage the IND/IDEs for more than
1100 active studies, monitor over 200 sites, and review nearly 10,000 SAE
reports per year. We possess the customer focus and adaptability of a midsized company and the global footprint of a large CRO. Headquartered in
Bethesda, MD, we are a certified woman-owned business.
TecHorizon S.r.l.
Booth: 2430
Thomson Reuters Life Sciences supports R&D productivity across the
Pharma lifecycle with respected and comprehensive intelligence solutions.
Offering unbiased scientific, competitive, regulatory, and generics information, analytics, and expertise for your organization, Thomson Reuters Life
Sciences empowers and enables effective, evidence-based decision-making
at every stage from discovery to launch and beyond. science.thomsonreuters.
com/pharma
Theorem Clinical Research is one of the industry’s leading full-service,
contract research organizations (CRO). A global organization with 1,000+
employees located throughout 27 countries, Theorem Clinical Research provides core CRO services for Phases I-IV, but with niche business units in the
areas of technical services, medical devices and pharmaceutics with speed,
flexibility and attention to detail to drive a high-quality performance.
ThreeWire, Inc.
Booth: 3237
Contact: Bruce Gould
Website: www.threewire.com
Phone: 952-852-5557
ThreeWire is a global patient recruitment, enrollment and management
provider focused on accelerating patient recruitment and enrollment for the
medical device, pharmaceutical, and biotech industries. We utilize a proven,
flexible, systematic approach with predictable and measurable outcomebased strategies backed by performance-based pricing. Our customized
recruitment programs provide value-based solutions, including real-time
tracking and reporting, across North America and Europe.
186
Exhibitor Directory
TIBCO Software
Booth: 1015
Contact: Ben McGraw
Website: spotfire.tibco.com
Phone: 703-208-3915
Trio Clinical Resourcing,
an Aptiv Solutions company
Contact: Laura Owen
Website: www.trioclinical.com
From early stage discovery to clinical development to marketing and sales
force optimization, Spotfire helps the world’s leading pharmaceutical, medical device, and biotech companies discover new therapeutics, develop their
pipeline of assets, launch their drugs to the market, and align marketing and
sales campaigns.
TKL Research, Inc.
Booth: 1217
Contact: Reid Tripp
Website: www.tklresearch.com
Phone: 201-587-0500
Booth: 2337
Contact: Jennifer Lansink
Website: www.totalrootconcepts.com
Phone: 530-581-2718
Phone: 919-401-1800
Trio Clinical Resourcing, an Aptiv Solutions company, is an international biopharmaceutical and medical device resourcing company that provides flexible solutions to meet your regulatory, clinical and safety staffing needs. Trio
offers flexible staffing models from individual, multiple and team placements
to being a full functional service provider. We also offer flexible contract
types, durations and staff locations.
Driving enrollment, Accelerated Timelines. TKL Research, Inc. is a full-service,
International CRO providing comprehensive trial management for Phase
1-4 studies. We offer an inpatient Phase 1 facility and specialized outpatient research clinics. Since 1944, we continue to deliver the highest level of
services to the Pharmaceutical and Healthcare markets. Our experience and
reputation for quality are coupled with close partnering with Sponsors in
designing customized clinical research programs.
Total Root Concepts, Inc.
Booth: 2915
TTC, llc
Booth: 2300
Contact: Marie Johnston
Website: www.ttc-llc.com/
Phone: 215-243-4103
TTC is the leader in global clinical trial cost benchmarking and has a proven
track record in all aspects of outsourcing cost management; from the budgeting of protocols and clinical trials to the negotiations with clinical sites and
other providers. TTC has leveraged the original innovation of a cost management tool to develop new state-of-the-art products to meet the needs of
pharmaceutical and biotech companies, and clinical sites and other providers
around the world.
Total Root Concepts is a training and communication company providing
site solutions for more effective program delivery: Pre-, During, and PostInvestigator Meeting. This includes: Face-to-Face Investigator Meetings,
Online Investigator Meetings, Regional Update and Recruitment Boost
Meetings, Site Rejuvenation Meetings, Study-Specific Portals with eLearning Modules, & DVD creation. Total Root Concepts creates a more powerful,
tailored message to drive BETTER site recruitment and enrollment!
UBC
Booth: 2101
Contact: Susan Couch
Website: www.unitedbiosource.com
Phone: 866-458-1096
UBC is a global medical and scientific affairs organization that partners with
life science companies to develop and commercialize their products. We
bring together scientific experts, research professionals, and technologies to
generate real-world evidence of product effectiveness, safety, & value. For
more information visit unitedbiosource.com.
TransPerfect
Booth: 2715
University of Iowa Pharmaceuticals Booth: 3015
Contact: Ryan Simper
Website: www.transperfect.com
Phone: 919-361-9200
Contact: Randy Yeates
Website: uip.pharmacy.uiowa.edu
TransPerfect leads the way in life sciences translation services and solutions.
Our next-generation approach centers around innovation, combining cuttingedge workflow technologies with the industry’s only quality management
system fully certified to EN 15038:2006 and ISO 9001:2008. When it comes
to clinical development, we speak your language.
Trifecta Multimedical
Booth: 2025
Contact: Deborah Novick
Website: www.trifectamultimedical.com
Phone: 310-385-8642
Phone: 319-335-8674
University of Iowa Pharmaceuticals (UIP) is an FDA-registered contract pharmaceutical manufacturing and analytical testing facility. UIP services include
clinical supply manufacturing, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis, and
stability studies. UIP is capable of handling controlled substances and potent
and cytotoxic compounds.
Trifecta Multimedical has extensive experience training clinical research sites
and optimizing site start-up and conduct. Trifecta’s minimally disruptive
solutions fit within, or can improve upon, existing Sponsor/CRO processes.
Their use allows clients to immediately realize significant cost savings and
reduce time lines. Trifecta provides innovation, globalization and execution
for projects of any size.
University of the Sciences
Booth: 1248
Contact: Christopher Miciek
Website: www.usciences.edu
Phone: 215-596-8597
Founded in 1821 in Philadelphia, University of the Sciences is a private, coeducational institution that focuses on advancements in applied health, pharmacy, and natural sciences. USciences has launched and enhanced thousands
of successful careers. Plus, six of the leading pharmaceutical companies were
founded by university graduates.
187
Exhibitor Directory
the Uppsala Monitoring Centre
Booth: 2907
Virtify, Inc.
Booth: 1842
Contact: Mats Persson
Website: www.umc-products.com
Phone: +46-186-560-60
Contact: Deeksha Taneja
Website: www.virtify.com
Phone: 617-252-0770 Ext. 3122
Virtify is the market leader in Structured Content Management software solutions for life sciences. Organizations rely on Virtify solutions to reduce timeto-market, risk & costs by managing and automating the complex regulatory
compliance and content exchange requirements throughout the product
life cycle. Virtify’s easy-to-use software suite is the industry’s only solution
to provide a secure, collaborative, web-based environment for managing
regulated content throughout the entire continuum.
The Uppsala Monitoring Centre’s main product WHO Drug Dictionary
Enhanced is used globally for coding and analyses of concomitant medication data collected in Clinical Trials & Drug Safety Operations. We are now
introducing the Drug Dictionary China and the Cross Reference Tool Japan,
come to our booth for a demonstration.
Valesta Clinical Research
Booth: 1319
Contact: Carolyn Benslimane
Website: www.valesta.com/
Phone: 866-445-2465
Valesta Clinical Research Solutions is a proven industry leader in placing
skilled clinical research professionals at all career levels in project-based,
contract-to-hire, and direct hire opportunities, both locally and globally. We
have a long track record of making successful job matches in specialized
areas, including clinical data, clinical monitoring, medical writing, biometrics,
and regulatory affairs.
Veeva Systems, Inc.
Virtual Clinical Solutions
Booth: 2400
Contact: Dale Jackson
Website: www.virtualclinical.com
Phone: 615-891-5443
VCS has over 12 years experience working with the Pharmaceutical and
Biotech Industry delivering training to investigational sites and study teams
around the globe. VCS has supported over 600 clinical studies and worked
with over 40,000 investigational sites in over 95 countries. To increase
understanding and comprehension of content by global site staff, VCS has
delivered training content in over 65 languages.
Booth: 1445
Contact: Brittany Machion
Phone: 484-588-4499
Website: www.veevasystems.com
Join the content management revolution! Veeva Vault is the first regulated
content management system built, from the ground up, specifically for the
life sciences industry. Based on the very latest in cloud computing technology, Vault requires no hardware or software to purchase, install or maintain.
Vault spans the industry’s major business processes with end-to-end applications that are simple-to-use, simple-to-administer and inexpensive to operate
for organizations of all sizes.
Verified Clinical Trials
Booth: 1712
Contact: Mitchell Efros
Email: DrEfros@verifiedclinicaltrials.com
Website: www.verifiedclinicaltrials.com
Phone: 516-998-7499
Booth: 2739
Contact: Bryan Adams
Website: www.veristat.com/
Phone: 508-429-7340
Booth: 3116
Contact: Chris Gilman
Website: www.virtualscopics.com
Phone: 585-249-6231
VirtualScopics is a leading imaging core lab providing central reads and
quantitative imaging solutions for drug and medical device clinical trials.
Therapeutic area expertise includes: oncology, musculoskeletal, neurology,
cardiovascular and medical devices utilizing MRI, PET, CT, Ultrasound, DEXA,
Bone Scans and X-Ray imaging modalities.
Vitalograph
Booth: 2518
Contact: John Buchholz
Website: www.vitalograph.co.uk
Phone: 913-888-4221
We provide innovative EDC solutions in respiratory clinical trials: 1. Spirotrac®
Centralized Spirometry 2. In2itive e-Diary for ePRO solutions & validated
questionnaires 3. Integrated Spirometry, Diary and FeNO 4. VIEWER web
portal 5. PM & CDM. Currently providing our services in global Phase II, III, and
IV studies with regular repeat business.
Verified Clinical Trials is a forward thinking company developed by experts
active in the clinical research community to proactively improve research
subject safety and data quality in clinical research trials. Verified Clinical Trials
defines itself as the world’s leader in the field of database registries in clinical
trial research.
Veristat, Inc.
VirtualScopics
Wake Research Associates
Booth: 2949
Contact: Earl Seltzer
Website: www.wakeresearch.com
Phone: 919-781-2514
Wake Research Associates is an independent multi-center clinical research
group designed to work closely with and meet the needs of the pharmaceutical industry and CROs in the conduct of Phase I-IV trials. We are known for
effectively combining strategic patient recruitment and retention with high
quality clinical research procedures. Our approach is uncompromising - each
study conducted at our site is carefully planned and executed according to
regulations with superior quality.
Veristat, a clinical research organization and CDISC Solution Provider,
provides strategic consulting, biostatistics, SAS programming, medical
writing, and clinical data management services to life science companies. In
addition, Veristat supports regulatory submissions through the preparation of
integrated summary documents and submission-ready CDISC data. Based on
over 15 years of experience, Veristat provides flexible, innovative, and sciencefocused services customized to our clients’ needs.
188
Exhibitor Directory
WCCT Global
Booth: 1727
Contact: Christopher Theo
Website: www.wcctglobal.com
Phone: 714-553-8176
Western Institutional Review Board
(WIRB)
Booth: 2107
Contact: Linda Morrison
Website: www.wirb.com
Phone: 360-252-2443
WCCT Global is an early phase drug development clinical CRO, based in the
United States with 150 beds in 2 locations. As a drug development partner,
WCCT Global partners with domestic and foreign innovator companies
who need regulatory and strategic development support from First-in-Man
through the Proof of Concept stage. WCCT Global also specializes in special
patient population phase 1 studies that require complex study designs and
procedures including thorough QTc and ethnobridging studies.
At the forefront of human research safety for more than 40 years, WIRB continues to deliver leadership, proven expertise, and quality services to medical
researchers worldwide. WIRB’s expertise ensures indisputable review quality
safeguarding both Investigator and human subjects. WIRB’s customized
services, training, and consulting accelerate research review and implementation. WIRB helped forge and remains the gold standard in research today for
protecting human subjects and advancing research.
WCI Consulting Limited
Booth: 2243
Whitsell Innovations, Inc.
Booth: 1740
Contact: Kate Derham
Website: www.wcigroup.com
Phone: +44-2392-268133
Contact: Natalie Becker
Website: www.whitsellinnovations.com
Phone: 919-636-5839
Founded in 1986, WCI is the leading life science consulting practice focusing on Patient Safety, Medical Affairs, Benefit and Safety Risk Management,
Quality and Compliance, Labelling, and medical Governance. We have
worked with over 50 pharmaceutical, biotechnology, consumer health,
medical device, and dietary supplement organizations; helping to implement
solutions which assure compliance and boost performance.
WebbWrites, LLC
Booth: 2044
Contact: Stephanie Dedrick
Website: www.webbwrites.com
Phone: 919-433-0820
Whitsell Innovations, Inc. is a medical and scientific writing company. We
provide regulatory documents for clinical and pharmaceutical development (pre-clinical through post-marketing), including full submissions. We
write meeting packages, CMC development reports, validation and stability
protocols and reports, clinical protocols, clinical study reports, narratives,
manuscripts, CME content, and literature reviews. Our singular focus is perfect communication for our clients’ target audience.
Extensive experience in regulatory document preparation, ability to provide
a full range of statistical services, and provision of superior products due to
continuity of personnel, flexibility to work onsite with clients, unsurpassed
customer service, and capacity to meet aggressive timelines. WebbWrites
has prepared more than 71 New Drug Applications in 14 years.
WebWise Learning, Inc.
Booth: 1949
Contact: Marge Krohn
Website: www.webwiselearning.com
Phone: 952-883-0800
Wingspan Technology Inc.
Booth: 1128
Contact: Meghan McKeown
Website: www.wingspan.com
Phone: 610-941-6500
Wingspan Technology, Inc, the leading provider of Documentum to
SharePoint integration software, is the maker of the DocWay products and
Wingspan eTMF. Founded in 1996, Wingspan provides innovative technology
solutions and offers in-depth industry knowledge and experience to companies in life sciences and pharmaceutical industries.
Wipro Technologies
WebWise Learning brings extensive industry knowledge together with
instructional design experience and technology expertise to develop effective interactive online learning and web-based process- and procedurerelated job support tools for the pharmaceutical, biotech, medical device,
and healthcare industries. We offer off-the-shelf, customizable, and custom
company-specific solutions.
The Weinberg Group
Booth: 3243
Contact: Jeff Antos
Website: www.weinberggroup.com
Phone: 202-280-0815
Booth: 2900
Website: www.wipro.com
Wipro (NYSE: WIT), services 5 of the top 10 Pharmas globally and exceeds
$6B in annual revenue as a global leader in consulting, technology, BPO
and R&D solutions. We are the leader in providing pharma with a range of
services and accelerators with best practices covering EDC, CTMS, Safety,
Collaboration Portal and CDR in a SaaS delivery model.
The Weinberg Group is a global scientific and regulatory consulting firm
headquartered in Washington, D.C. In our 28 years of experience, we have
assisted all types of companies by applying our knowledge of the complexities of the regulatory pathway to remediate, maintain and improve regulatory
compliance. Our capabilities span from regulatory strategy and submissions
to compliance and scientific product support.
World Courier, Inc.
Booth: 1213
Contact: Nicole Murback
Website: www.worldcourier.com
Phone: 516-354-2600
With over 150 offices in 51 countries – all ISO 9001 certified- World Courier
has the network, trained personnel and resources to manage the most
demanding research project, biologic , or pharmaceutical shipment.
Worldwide Clinical Trials
Booth: 1913
Contact: Freyja Cheng
Website: www.adicon.com.cn
Phone: +86-21 54298073
ADICON Clinical Trial Center, a leading full-service central lab for clinical trials
in China, conducts activities to support new pharmaceutical developments
including clinical trials and CRO (contract research organization) business.
The company’s comprehensive support for clinical trials contributes to realizing rapid and high quality pharmaceutical development.
189
Exhibitor Directory
X Factor Advertising
Booth: 2313
Contact: Mike Lakey
Website: www.xfactoradvertisting.com
Phone: 503-235-6249
NOTES
X FACTOR ADVERTISING (XFA) is an industry leader in patient recruitment services. As a full-service agency we specialize in the development
and implementation of creative, media and tracking strategies to assist in
the recruitment and retention of patients for clinical trials. XFA works with
individual sites, CRO’s and pharmaceutical companies and has developed
successful campaigns supporting recruitment in 11 countries throughout
North America, South America and Europe.
Xerimis Inc.
Booth: 1916
Contact: Kevin Clover,
Business Development Executive
Phone: 856-727-9940
Website: www.XERIMIS.com
CUSTOMIZED CLINICAL PACKAGING - “Your Project, Your Timeline”
* Phase I-IV Project Mgmt. * DEA Lic.: Sched. III-V * Protocol Analysis,
Package/Label Design, Supply/Distrib. Strategies * “CAPS” - Customized
Accelerated Packaging Solutions * Primary/Secondary Packaging Thermoform/Coldform Blistering - Auto./Manual Bottle Fill * Multi-Lingual
Label Generation * Monitoring/Global Distrib.: Controlled Room Temp.,
Refrig./Frozen Conditions * Import/Export Coord. * Returned Supplies
Accountability/Destruction
Y-Prime LLC
Booth: 1138
Contact: David Espenshade
Website: www.y-prime.com
Phone: 610-675-6373
Y-Prime LLC is a premier eClinical products and consulting company that
leverages groundbreaking platform technology and systems intelligence to
provide novel, personalized decision making solutions to life sciences companies. Since 2006, Y-Prime has developed a robust franchise of enterprise,
clinical and operations solutions that offer the potential to dramatically
accelerate time to market while significantly reducing costs.
Zinc Ahead, Inc.
Booth: 3149
Contact: Hamish Miller
Website: www.zinc-ahead.com
Phone: 212-971-9710
Developed and refined over the course of almost a decade, Zinc MAPS is the
world’s leading promotional compliance solution designed specifically for
the life science industry. A web–based application which places the entire
approval process online, Zinc MAPS drives compliance, quality and efficiency
into approval processes. With clients in over 100 countries, Zinc Ahead is
the world’s leading provider of promotional compliance solutions designed
specifically for the life science industry.
190
PRECONFERENCE PROGRAMS AND TUTORIALS — Sunday, June 24
(as of February 1, 2012)
DIA 2012 features many extended opportunities for you to network and learn. The Annual Meeting Preconference Tutorial Program is
an excellent opportunity to jump start your learning before the DIA 2012 Annual Meeting. Each preconference tutorial is led by subject
matter experts who will provide in-depth instruction on some of today’s hottest topics. Each preconference tutorial is designed to increase
your knowledge in specific subject areas while allowing for small group interaction. Offerings are either full-or half-day opportunities.
Related tracks/interest areas are indicated to the right of the tutorial title.
Monitor www.diahome.org/registerDIA2012 frequently for updates to the Preconference Programs and Tutorials.
Morning Tutorials, Half-day — 8:30 AM–12:00 PM
Tutorial 20
Tutorial Fee: $405.00
Japan Regulatory Environment: Overview of the Organization, Processes,
Systems, and Changes Affecting Pharmaceutical Development
See page 192 for details.
FDA Enforcement: Understanding the Agency’s Authority, How Violations
Occur, How to Prevent Them, and How to Respond if Violations Do Occur
Tutorial 22
Utilizing Chemistry, Manufacturing, and Controls in Drug Development
Tutorial 23
Global Market Access: Essential Knowledge for Clinical Trial Design
Tutorial 24
Tutorial 25
Benefit and Harm: A Process to Express this Ratio Determined by ConsensusCANCELLED
driven Evidence
Tutorial 21
Afternoon Tutorials, Half-day — 1:00 PM–4:30 PM
Tutorial 30
Regulatory Affairs in the European Union: An Overview of Registration
Procedures for Medicinal Products in the EU
Tutorial 31
Leadership: How to Organize and Lead People in Group Work
Tutorial 32
Designing, Operating, and Evaluating Patient Registries
Tutorial 33
Understanding Comparative Effectiveness Research (CER)/Health Technology
Assessment (HTA) in the Biopharmaceutical Industry
Tutorial 34
9:00 AM-6:30 PM SAFE-BioPharma®: Trusted Identities for Cloud Collaboration
CANCELLED
1:00 PM-6:00 PM APCR: Win-win Strategies for the Sponsor-investigator Relationship
Full-day Tutorials — 9:00 AM–5:00 PM*
Tutorial 40
Understanding and Navigating the Regulatory System in China
Tutorial 41
Quality Oversight of CROs - Clinical Vendors
Tutorial 42
Tutorial 43
st
Tutorial 44
Landscape for Phase 1 Trials
Early Phase Research: Navigating the 21 Century CANCELLED
Tutorial 45
Preparing for a US FDA Advisory Committee Meeting *ADJOURNS AT 3:45 PM
Tutorial 46
Fundamentals of Project Management for Nonproject Managers
*ADJOURNS AT 4:30 PM
Tutorial 47
Tutorial 48
Register for these tutorials and the Annual Meeting online or
fax the completed registration form on page 204 to DIA at +1 215.442.6199.
191
Tutorials, Sunday, June 24
Refer to page 3 for Track/Interest Area Descriptions
MORNING TUTORIALS, HALF-DAY
Fee: $405.00
8:30 AM-12:00 PM
TUTORIAL 20
TUTORIAL 21
Track 08
Related Interest Area(s): RA, QAQC
FDA Enforcement: Understanding the
Agency’s Authority, How Violations Occur,
How to Prevent Them, and How to Respond
if Violations Do Occur
Track 08
Continuing Education Credit: IACET – .3 CEUs
Regulatory Affairs Certificate Program: 2 Elective Units
Related Interest Area(s): RA, PR, CEHTAEbM
Japan Regulatory Environment: Overview of the
Organization, Processes, Systems, and Changes
Affecting Pharmaceutical Development
Instructor
Michael A. Swit, Esq., JD
Founder
Law Offices of Michael A. Swit
Major changes in Japanese pharmaceutical regulations are impacting
the development of new drugs in Japan as well as global development
programs. This tutorial will describe the major elements of the regulatory system including the Pharmaceuticals and Medical Devices Agency
(PMDA), regulatory processes during development (consultations), and
J-CTD review. Several development strategies necessary to meet Japanese
requirements for new drug approval will be identified. Postmarket surveillance and pricing reimbursement processes will be reviewed, and finally,
the impact of the changing regulatory system on global strategies will be
identified throughout development, registration, and postmarket stages.
This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2012 and beyond (e.g., application integrity policy and GMP/GCP requirements), (2) FDA administrative
enforcement weapons and how the Agency uses them (e.g., inspections,
warning letters, publicity, recalls, and investigator disqualification proceedings), and (3) the civil and criminal penalties for violations (e.g., seizure, injunction, criminal prosecution). Included in our focus will be FDA’s renewed
commitment to enforcement as articulated in an August 2009 speech by
Commissioner Margaret Hamburg. We also will address how to handle an
FDA enforcement action should you face one, particularly in the wake of an
inspection or Warning Letter and the impact of the new initiatives related
to responding to 483s and Warning Letters implemented in 2009 following
Commissioner’s Hamburg’s pledge to boost enforcement. These interactive discussions will focus on how FDA operates and makes decisions and
how to respond effectively, using tactics ranging from negotiation to, when
appropriate, litigation.
Learning Objectives
Learning Objectives
At the conclusion of this tutorial, participants should be able to:
Instructor
Alberto Grignolo, PhD
Corporate Vice President
Global Strategy and Services
PAREXEL Consulting
đƫ
đƫ
đƫ
đƫ
đƫ Explain the major elements of the Japanese regulatory system
đƫ Describe the regulatory processes during development, registration,
and postapproval
đƫ Discuss specific attributes in the Japanese regulatory system and
their impact on multinational development strategies
Discuss FDA’s enforcement priorities for 2012 and beyond
Describe FDA’s compliance review and decision-making process
Identify the legal risks and penalties for noncompliance
Respond appropriately to FDA enforcement
Target Audience
Target Audience
This tutorial is designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP
rules, regardless of whether in a supervisory or direct role.
This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers/instructors are their own opinion
and not necessarily that of the organization they represent, or that of the Drug Information Association.
Speakers/instructors and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
192
TUTORIAL 22
impact product usage. This tutorial will provide an overview of global
reimbursement systems including health technology assessments (e.g.,
NICE), and discuss ways in which evidence of value from clinical trials can
help or limit market access.
Track 12
Related Interest Area(s): CMC, RA, QAQC
Utilizing Chemistry, Manufacturing, and
Controls in Drug Development
Learning Objectives
đƫ Summarize the evidence demands of global payer customers
đƫ Discuss the growing importance of the reimbursement hurdle to
patient access to your medicine
đƫ Recognize how aspects of clinical trial design, such as dosing and
comparator choice, can impact reimbursement potential
Instructor
Priya Jambhekar
Target Audience
This tutorial is designed for pharmaceutical industry employees not familiar with market access (pricing, reimbursement, health economics) issues.
President
PBS Regulatory Consulting Group Inc.
This tutorial will provide you with the tools to write or assemble CM&C
sections of regulatory submissions and other regulatory documents, and
adequately prepare you for CM&C meetings with the FDA.
TUTORIAL 24
Participants will discuss all the CM&C components of INDs and NDAs/
CTDs, provide appropriate tools to write or assemble CM&C sections of
regulatory submissions and documents, prepare for CM&C meetings with
FDA, and navigate through the myriad guidelines and guidance documents.
Continuing Education Credit: CME – 3.25 AMA PRA Category 1 Credit(s)™ ;
IACET – .3 CEUs
Learning Objectives
đƫ Recognize FDA’s regulatory expectations and the regulatory
framework
đƫ Outline the CM&C sections of INDs/NDAs/CTDs/DMFs
đƫ Assemble the CM&C sections of INDs and NDAs/CTDs
đƫ Describe regulatory documents affected by CM&C
Instructor
Barry S. Sall, RAC
Target Audience
Principal Consultant
PAREXEL Consulting
This tutorial is designed for regulatory affairs professionals, quality assurance and compliance personnel, and manufacturing personnel.
TUTORIAL 23
Track 09
Related Interest Area(s): CmbP, MDD, RA
Get up to speed on medical device clearances and approvals! This tutorial demystifies FDA’s medical device requirements. We will explain and
provide a decision matrix for 510(k)s and PMAs, as well as a matrix to
clarify IDE requirements. Attendees will use that matrix to determine the
appropriate pathway for public record/fictional products and explore the
strategic implications behind the submission and its indications. We will
examine investigational device exemptions, and discuss the role of IRBs
and the level of FDA oversight as the trial proceeds.
Track 13
Related Interest Area(s): PR, CEHTAEbM, CR
Global Market Access: Essential Knowledge for
Clinical Trial Design
Learning Objectives
Clinical Research Certificate Program: 2 Elective Units
đƫ Distinguish between 510(k)s and PMAs and their strategic
advantages
đƫ Describe the scope of IDEs (exempt, nonexempt, SR)
đƫ Explain the nature and type of IRB including sponsor oversight
đƫ Identify major risks and the impact of new regulatory initiatives
Instructor
John Brennick, MPA
Target Audience
This tutorial is designed for regulatory affairs (RA) managers, business
development managers and staff; principal investigators, IRB members,
clinical research associates (CRAs), academic sites; lawyers, R&D, and
those working on combination products, cross-functional medical products and those wishing an introduction to devices.
Worldwide Market Access
Janssen Global Services, LLC
Reimbursement approvals from payers (reimbursers) have become as
important as regulatory approvals for pharmaceutical product success and
providing access to patients. Even with reimbursement approval, payer
restrictions such as step edits and individual patient approval significantly
193
TUTORIAL 25
AFTERNOON TUTORIALS, HALF-DAY
Track 14
Related Interest Area(s): CP, CR, MDD
1:00
Benefit and Harm: A Process to Express this Ratio
Determined by Consensus-driven Evidence
IACET – .3 CEUs; Nursing CANCELLED
– 3.25 contact hours
PM-4:30 PM
Fee: $405.00
TUTORIAL 30
Track 08
Regulatory Affairs in the European Union:
An Overview of Registration Procedures
for Medicinal Products in the EU
Instructors
Lee S. Simon, MD
Consultant
SDG LLC
Instructor
Brenton E. James, FTOPRA
Consultant, Strategic Regulatory Affairs
in the European Union, UK
Maarten Boers, MD, PhD, Msc
Professor of Clinical Epidemiology
University of Amsterdam, Netherlands
This tutorial will provide an overview of the three regulatory procedures
in the European Union — centralized, decentralized, and mutual recognition — including details on the review time to approval and opportunities
for sponsor/agencies dialogue from scientific advice to granting the
Marketing Authorization. It will discuss which procedure is available for
NCE including orphan drugs, OTC, and generic products, and examine
the business strategic opportunities for each procedure.
The importance of defining the benefits and potential harm of a therapy
are well known; however stakeholders perceive the expressed benefit
of any therapy differently. This tutorial will address how to measure the
understanding of benefit and harm by all stakeholders including patients,
and how to develop programs which ensure that all voices are heard.
This will encourage a better understanding of how best to measure this
information.
Learning Objectives
Learning Objectives
đƫ Explain the background of the development of the European
Union
đƫ Describe the three regulatory procedures for a marketing
application in the European Union for NCE, OTC, and generic
products
đƫ Identify the business considerations of translations, co-marketing,
co-promotion, patents, and trademarks
đƫ Recognize the importance of expressing benefit and harm in a way
that is understandable by all stakeholders including patients
đƫ Describe a process to define the benefit and harm of therapeutic
interventions
Target Audience
Target Audience
This tutorial is designed for anyone interested in developing drugs for
treatment of patients including clinical trialists, pharmacists, and professionals in the field of marketing, regulatory affairs, sales, pharmacovigilance, medical affairs, device makers and developers.
This tutorial is designed for attendees with an interest in European regulatory affairs (regulatory affairs staff, clinical research and development
managers, and project managers).
194
TUTORIAL 31
Track 16
Related Interest Area(s): All
Leadership: How to Organize and
Lead People in Group Work
Leanne Larson, MHA
Continuing Education Credit: IACET – .3 CEUs; PMI – 3.25 PDUs,
PMI #: 2166-000127
Project Management Certificate Program: 2 Elective Units
Vice President, Strategic Development
Outcome
In this interactive tutorial, the instructors will discuss practical issues
in designing and operating patient registries including: when a registry
is an appropriate approach to a requirement or research question;
how to design and plan patient registries to address different purposes; operational issues (site recruitment, patient retention, and data management);
issues and implications of secondary data use; HIPAA and Common Rule
issues; and useful analytic approaches.
Instructor
Michael Laddin, MBA, MS
CEO
LeaderPoint, LLC
Learning Objectives
The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This
tutorial addresses those issues by exploring the types of work groups,
how they can be more effective, and how individuals can correct group
dynamics and help the group achieve higher levels of performance.
đƫ Identify key characteristics of patient registries
đƫ Design registries for specific goals
đƫ Apply best practice and enhancement recommendations to create a
high-quality registry
đƫ Discuss emerging challenges with registries and how they are being
addressed
Learning Objectives
Target Audience
This tutorial is designed for regulatory affairs professionals, epidemiologists,
drug safety professionals, medical affairs professionals, pharmacovigilance
and quality management professionals, and clinical affairs professionals.
đƫ Identify the different types of work group structures and be able to
predict the quality of work the group will produce
đƫ Identify and correct dysfunctional group dynamics
đƫ Create and maintain cooperation among team members including
cross-functional teams
Target Audience
TUTORIAL 33
This tutorial is designed for individuals who must manage group activities
on a permanent or project basis, for those who must work on teams
but are not in charge of teams and are interested in learning how to
exert influence on group behavior, and for individuals to whom project
managers report.
TUTORIAL 32
Track 13
Related Interest Area(s): CEHTAEbM
Understanding Comparative Effectiveness
Research (CER)/Health Technology Assessment
(HTA) in the Biopharmaceutical Industry
IACET – .3 CEUs; Nursing – 3.25 contact hours; Pharmacy – 3.25 contact
hours or .325 CEUs (knowledge) (286-000-12-504-L04-P)
Track 13
Related Interest Area(s): CEHTAEbM, CP, CR
Designing, Operating, and Evaluating
Patient Registries
IACET – .3 CEUs; Nursing – 3.25 contact hours; Pharmacy – 3.25 contact
Instructors
Nancie E. Celini, MPH, DrPH
Chief Learning Consultant
CAB, Inc.
Instructors
Vadim Tantsyura, MS, MA, DrPH
Director, Data Management
Infinity Pharmaceuticals
President and CEO
Outcome
195
Health care reform has amplified interest in Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA). CER/HTA may sound
threatening without a realistic context for what it is, how it has evolved,
what it is intended to do and its limitations. A brief introduction and
overview of Comparative Effectiveness Research (CER)/Health Technology
Assessment (HTA) will be presented through lecture, interactive discussions and case study. This tutorial will present a perspective of CER/HTA
in the context of clinical trials and health care policy and provide timely
insights for today’s biopharmaceutical professionals.
progression through the preclinical process into early clinical programs
will be presented in this half-day tutorial targeted to familiarize pivotal
staff in start-up companies with the required terminology and functions,
pharmaceutical/biological companies that have yet to file INDs, and those
who want to improve their early development approach.
Learning Objectives
đƫ Identify ways to tailor the development, streamline the process, and
interact with FDA
đƫ Explain the specialties and resources needed to develop a product
đƫ Design processes to guide your company smoothly through the
progression of research and development
This tutorial will provide:
đƫ An introduction to origins of CER/HTA and key terminology and
concepts
đƫ Overview of some of the entities with responsibility for CER/HTA
đƫ A brief review of current literature
đƫ Components of CER/HTA using a case study as an example
đƫ Recommended resources for continued learning
Target Audience
This tutorial is designed for pivotal staff in start-up companies, pharmaceutical/biological companies that have yet to file INDs, and all personnel
who want to broaden their knowledge of product development.
Learning Objectives
đƫ Describe the origins of the models for conducting Comparative
Effectiveness Research (CER)/Health Technology Assessment (HTA)
đƫ Identify methodological problems and solutions in developing the
evidence base and the role of CER/HTA
đƫ Discuss CER/HTA examples applicable to the biopharmaceutical
industry
FULL-DAY TUTORIALS
9:00
Target Audience
This tutorial is designed for professionals in the biopharmaceutical industry who are interested in gaining practical insights into how CER/HTA
evolved, what the literature says about its use in industry, and the basics
of how it is performed, as well as its benefits and limitations. This tutorial
is ideal for those new to CER/HTA and interested in pursuing further study
in this field.
TUTORIAL 34
AM-5:00 PM
Fee: $755.00
TUTORIAL 40
Track 08
Related Interest Area(s): RA, CR, PR
Understanding and Navigating the Regulatory
System in China
Track 08
Related Interest Area(s): RA, RD, CR
IACET – .3 CEUs
Instructors
Laurence Bin Huang, MS
Regulatory Affairs Director
AstraZeneca Pharmaceutical Co., Ltd., China
Instructor
President
MORIAH Consultants
Wendy Yan, PharmD
Global Regulatory Strategist
Global Regulatory Affairs, Asia
Bayer Healthcare Co. Ltd.
There are 14 steps from research to development (R to D) and initiation of
phase 3 clinical studies; the majority of time committed to drug development occurs during this period. A discussion of the 14 critical steps from R
to D will include identifying ways to streamline the process and interactions with FDA. With each of the 14 steps used to develop the optimal
strategic plan, discussion will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth
This tutorial will provide an overview of the regulatory system in China,
including the agencies and institutions at the central government and
provincial levels, as well as their roles and responsibilities. Various regulations for product registration, clinical trials, and safety reporting will be
presented, and the regulatory pathways and strategic considerations for
196
clinical trial and marketing applications will be discussed. A step-by-step
roadmap of how to navigate the regulatory system in China for clinical trial
approval and product registration will also be discussed. This discussion
will include key points to consider, strategies, and tactics.
FDA and EMA communicate at industry conferences, FDA-CTTI meetings,
and regulatory agency public meetings. Sponsors and CRO-vendors who
are transferred the responsibilities for trial conduct must have in place a
vendor management-oversight program and methods, as well as a quality
management system and risk management framework for the execution
of clinical trials. Building upon this framework and benchmarking to ISO9001: 2008, Quality Management Systems, this tutorial describes Quality
Oversight of Vendors, with the focus on quality systems, quality attributes,
and performance monitoring.
Learning Objectives
đƫ Describe the regulatory system in China, including the agencies
and institutions and their roles and responsibilities in the regulatory
processes for clinical trial and registration approval, as well as safety
reporting
đƫ Explain the history and the recent changes in the regulatory system
in China and future perspectives
đƫ Describe the regulatory pathways and strategic considerations for
successful clinical trial and marketing applications in China
đƫ Discuss how to navigate the regulatory system in China for clinical
trial approval and product registration
PANEL DISCUSSION:
Learning Objectives
đƫ Discuss quality management systems principles and methods in the
context of clinical program management and vendor oversight
đƫ Identify two (2) key elements of an internal communication plan for
vendor oversight that supports both business and team successes
đƫ Identify two (2) metrics for utilization when outsourcing a clinical
trial to a vendor
Target Audience
This tutorial is designed for professionals involved in regulatory affairs,
clinical research, pharmacovigilance/drug safety, project management,
R&D strategies, and quality assurance and quality control.
TUTORIAL 41
Target Audience
This tutorial is designed for professionals involved in clinical research, clinical operations, outsourcing, regulatory affairs, quality compliance, project
management and commercial-medical affairs. Sponsors, CROs, ACROs,
AROs, as well as personnel from the NIH, DoD, and VA will also find this
tutorial valuable.
Track 03
Related Interest Area(s): CR, OS, RA
Project Management Certificate Program: 4 Elective Units
TUTORIAL 42
Track 08
Related Interest Area(s): RA, QAQC, PM
Continuing Education Credit: IACET – .7 CEUs; Pharmacy – 6.5 contact
Instructors
Liz Wool, BSN, RN, CCRA, CMT
President and CEO
QD-Quality and Training Solutions, Inc.
Instructor
Carol H. Danielson, MS, DrPH
NO PHOTO
President
Regulatory Advantage
AVAILABLE
Jennifer J. Poulakos, PhD
Director, Clinical Quality Assurance
Astellas
Participants in this tutorial will learn the differences between traditional
biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific
biologics such as vaccines and gene therapy, and the different ways that
CBER and CDER view product development.
Learning Objectives
đƫ Discuss product jurisdiction and how it affects the review of biologic
products
đƫ Identify the unique aspects of biologics and how their development
compares to that of small molecules
Vice President, Operations
Metrics Champion Consortium
197
đƫ Describe the unique CMC compliance reporting aspects of biologics
đƫ Discuss the regulatory mechanisms available to speed biologics
development
đƫ Explain the current regulatory, global, and public opinion trends that
have the potential to impact biologics
TUTORIAL 44
Early-phase Research: Navigating the 21st Century
Landscape for Phase 1 Trials
Target Audience
Continuing Education Credit:
CME – 6.5 AMA PRA Category 1 Credit(s)™ ;
CANCELLED
IACET – .7 CEUs; Nursing – 6.5 contact hours
This tutorial is designed for professionals involved in regulatory affairs,
quality assurance, and project management.
TUTORIAL 43
Track 04
Related Interest Area(s): PC, CR, RD
Track 01
Instructors
Nancy A. Lass, MD
Related Interest Area(s): CR, ST, MW
President and Principal Consultant
NL Specialty Consulting, Inc.
IACET – .7 CEUs; Pharmacy – 6.5 contact hours or .65 CEUs (knowledge)
(286-000-12-503-L04-P)
Stacie J. Bell, PhD
Assistant Director, Clinical Pharmacology
Array BioPharma, Inc.
Instructor
Michael C. Mosier, PhD
Director, Biostatistics
This tutorial will introduce basic statistical concepts that are fundamental
to clinical research. It is designed for individuals with some exposure to
statistics (either through course work or on-the-job experience) that is
equivalent to an introductory statistics course. While a few formulae are
included for individuals who are interested in computational details, the
overall emphasis of the tutorial will be on the application of statistical
concepts to clinical investigation.
President
DWD & Associates
Learning Objectives
Howard E. Greenberg, MD, MS, MBA
đƫ Discuss basic statistical concepts such as variability, confidence
intervals, hypothesis testing, and p-values
đƫ Compare various study designs and identify techniques to
avoid bias
đƫ Use statistical terminology with ease
đƫ Distinguish information needed for determining sample size
Principal
HEG Associates
This tutorial will provide an overall approach to Phase 1 study operations
in three sections. The first section will address the scientific considerations
underlying study protocols and key concepts for successful conduct of the
study. The second section will provide an overview of regulatory concepts,
e.g. Good Clinical Practice, working with IRBs, essential regulatory documents and reporting, and aspects of monitoring and auditing studies, etc.
The final section will cover business aspects and site operational management, e.g. site selection and personnel, recruitment, facilities management,
budgets and contracts, etc. Opportunities for practical application of
concepts will be included.
Target Audience
This tutorial is designed for professionals in the pharmaceutical industry
involved in clinical research, medical affairs, medical writing, and other
disciplines, who need to be familiar with statistical concepts.
198
Learning Objectives
Learning Objectives
đƫ Describe at least two commonly used Phase 1 study designs including a basic protocol design for each
đƫ Identify at least three essential regulatory documents for Phase 1
clinical studies
đƫ Define at least two examples of high-quality clinical practices for
investigators, sponsors and clinical trial protocols
đƫ List at least four site operational processes that are core to the conduct of an early phase study
đƫ Identify the critical factors in preparing for a successful Advisory
Committee meeting
đƫ Recognize and evaluate those factors that are most applicable to
your team
đƫ Design the most effective preparation for your team(s)
Target Audience
This tutorial is designed for professionals in regulatory affairs, clinical
research leads, and corporate executives.
Target Audience
This tutorial is designed for individuals involved in early phase research
at the investigational site, contract research organizations or as sponsors, who are interested in a basic overall understanding of Phase 1 study
operations. Topics covered will be relevant for investigators and medical
oversight, clinical managers and monitors, project managers, business
managers, regulatory affairs managers, quality assurance auditors and
other areas of study support.
TUTORIAL 46
Track 02
Related Interest Area(s): PM, BT, MDD
Fundamentals of Project Management for
Non-project Managers
** ADJOURNS at 4:30 PM
Continuing Education Credit: IACET – .6 CEUs; PMI – 6 PDUs,
PMI #: 2166-000132
TUTORIAL 45
Track 08
Preparing for a US FDA Advisory
Committee Meeting
** ADJOURNS AT 3:45 PM
Regulatory Affairs Certificate Program: 4 Core Units
Instructor
Joan Knutson, PMP
PM Guru Unlimited
Instructor
Pete Taft
This tutorial will focus on the basic principles of project management, and
how they can be applied to best meet the needs of your projects. You will
take away a set of project management skills and techniques that can be
immediately put to use.
Founder and CEO
Taft and Partners/PharmApprove
Learning Objectives
What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be
one of the most challenging and grueling experiences for any drug,
device, or biologic team. In just eight short hours with the FDA Advisory
Committee, you not only must thoroughly explain but also defend, in
detail, your product in a highly visible, high-stakes public meeting. This
course teaches best practices for preparing for an FDA Advisory Committee meeting.
đƫ Decide when work effort should be treated as a project
đƫ Use the four-step model to manage projects
đƫ Apply motivational and team-building techniques to gain support
and buy-in
đƫ Employ practical leadership and communication skills to ensure
coordination and collaboration during the project
Target Audience
This tutorial is designed for biotechnology/pharmaceutical/medical
device professionals who are looking to learn more about the project
management process and how to apply it to their specific job
responsibility.
What You Will Learn
đƫ
đƫ
đƫ
đƫ
What is an Advisory Committee?
What does an Advisory Committee look like?
Critical factors for Advisory Committee preparation
How to design the most applicable preparation program for your
team
đƫ Top ten “Best Practices” and “Must Avoids”
199
TUTORIAL 47
Track 16
TUTORIAL 48
Track 06
Related Interest Area(s): CR, RA, MW
Continuing Education Credit: IACET – .7 CEUs; PMI – 6.5 PDUs,
PMI #: 2166-000131
Clinical Research Certificate Program: 4 Core Units
Clinical Research Certificate Program: 4 Core Units
Instructor
Patricia A. Matone, PhD
Instructor
George H. D’Addamio, PhD
President
Scientific Information Services LLC
President
PharmConsult, Inc.
This tutorial provides an in-depth analysis of the preparation of a Clinical
Overview for pharmaceutical products (drugs and biologics) in accordance
with ICH guidelines concerning development of Module 2.5 of a Common
Technical Document (CTD).
This tutorial will provide an introduction to the drug development process
under FDA and ICH Guidelines, including how various parts of companies
fit into the overall process of pharmaceutical development.
What You Will Learn
What You Will Learn
đƫ Objectives, structure, and format of the Clinical Overview is explored,
with attention given to developing a document suitable for multiregion submissions
đƫ Inclusion and presentation of clinical and nonclinical data, with
emphasis on how to effectively use the other technical summaries
within the CTD
đƫ Insight is provided on how to prepare a document that successfully
communicates the benefits and risks of the investigational product
đƫ How to frame the different sections of the Clinical Overview to best
communicate the product’s unique attributes
đƫ How to develop the Clinical Overview for other types of submissions
đƫ How the pharmaceutical industry identifies new products and brings
them to market
đƫ Contributions of key groups within the company and how they
interact
đƫ FDA and regulation of the industry
đƫ Basics of filing a New Drug Application (NDA)
đƫ Ethical considerations in conducting clinical research
đƫ Concepts and functions associated with ensuring overall study
quality
Learning Objectives
Learning Objectives
đƫ Recognize the process of discovering and developing new pharmaceutical products
đƫ Describe the activities associated with conducting clinical research
and reporting the results and responsibilities of various departments
in accomplishing these activities
đƫ Discuss institutional review, informed consent, and financial disclosure
đƫ Explain the concepts and functions associated with ensuring overall
quality of studies
đƫ Describe the organization of the FDA, their authority, and interactions with sponsor companies
đƫ Communicate the role of a Clinical Overview (Module 2.5) in a CTD
đƫ Describe the structure and format of a Clinical Overview in accordance with ICH guidelines
đƫ Develop strategies regarding the placement and presentation of
information in different sections of the Clinical Overview
đƫ Explain how to effectively cross-reference to other components of
the CTD
đƫ Develop a submission-ready Clinical Overview that successfully communicates all available information concerning the benefits and risks
of an investigational product
đƫ Recognize how to modify the Clinical Overview for different submission types
Target Audience
This tutorial is designed for professionals who work in the following areas:
clinical research, project management, administrative support, quality
assurance, regulatory affairs, manufacturing, medical writing, and business
support.
Target Audience
This tutorial is designed for clinical research and development professionals, medical writers, and regulatory affairs personnel involved in the
preparation or review of Module 2.5 of a CTD.
200
H OT E L LO C ATO R M A P
Please Note: Only attendees who book reservations at designated DIA hotels will have access to the DIA courtesy shuttle.
DIA is proud to partner with Travel Planners to offer you the lowest rates available for your conference hotel needs in Philadelphia. Log on to www.diahome.org/dia2012 and click on the hotel information tab to view a complete list of DIA hotels, many
of which offer early-bird rates and amenities exclusive to DIA attendees. In order to receive discounted rates and amenities,
reservations must be made through Travel Planners and not directly through the hotel. For best availability, please book prior to
May 25, 2012. After this date, rooms will be available on a space-available basis.
Online reservation is strongly encouraged, though hotel reservations can also be made by phone:
Monday – Friday, 9:00 AM–7:00 PM
+1.800.221.3531 (US/Canada) or +1.212.532.1660 (International)
[email protected]
Note: Travel Planners Inc. is the exclusive provider for all DIA 2012 hotel reservations. Please be advised that unauthorized third-party providers may contact you to book your reservations through them. These
providers may require non-refundable, fully pre-paid reservations that may be subject to steep cancellation and change fees. If you make a reservation with any provider other than Travel Planners, DIA will not be
able to assist you with any problems you may encounter with the terms of a third-party agreement.
B
FR
AN
KL
IN
18
PK
W
Y
VINE ST
VINE ST
LOGAN
SQUARE
WINTER ST
7
5
RACE ST
6
RACE ST
PENNSYLVANIA
CONVENTION
CENTER
4
CHERRY ST
8
12
ARCH ST
ARCH ST
1
FILBERT ST
JFK BLVD
16
14
CITY
HALL
MARKET ST
2
MARKET ST
13
20
LUDLOW ST
17
CHESTNUT ST
19
CHESTNUT ST
10
SANSOM ST
SANSOM ST
9
WALNUT ST
WALNUT ST
11
15
RITTENHOUSE
SQUARE
LOCUST ST
LOCUST ST
SPRUCE ST
SPRUCE ST
8TH ST
9TH ST
10TH ST
11TH ST
12TH ST
13TH ST
BROAD ST
15TH ST
16TH ST
17TH ST
18TH ST
19TH ST
20TH ST
21ST ST
3
H OT E L I N F O R M AT I O N
DISTANCE TO
CONVENTION
CENTER
EARLY-BIRD
SINGLE RATE*/
EXPIRES
POST EARLYBIRD SINGLE
ROOM RATE*
SHUTTLE**
1 Block
N/A
$216
No
Free Wi-Fi
2. Crowne Plaza Philadelphia
Downtown
1800 Market Street
8 Blocks
$172 – 4 night
minimum required 3/30/12
$182
Yes
Free Wi-Fi, local calls
3. Doubletree by Hilton Hotel
Philadelphia Center City
237 S. Broad Street
8 Blocks
$175
1/31/12
$185
Yes
Free Wi-Fi, local calls, daily
drawing for dinner for two
4. Embassy Suites
1776 Ben Franklin Parkway
6 Blocks
N/A
$195
Yes
Free Wi-Fi, full breakfast,
evening reception
1 Block
N/A
$179
No
Free Wi-Fi, local calls, complimentary
coffee vouchers, daily bottled water
8 Blocks
$254
3/30/12
$269
Yes
Free Wi-Fi, local calls
7. Hampton Inn Center City
1301 Race Street
1 Block
$166
3/30/12
$169
No
Free W-Fi, local calls, full breakfast,
24-hour coffee and tea
8. Hilton Garden Inn
1100 Arch Street
.5 Block
N/A
$208
No
Free Wi-Fi, daily coffee service,
drawing for dinner for two
9. Holiday Inn Express
Philadelphia Midtown
1305 Walnut Street
6 Blocks
N/A
$172
Yes
Free Wi-Fi, local calls,
continental breakfast
10. Hotel Palomar Philadelphia
117 South 17th Street
8 Blocks
N/A
$224
Yes
Free Wi-Fi for Kimpton In-Touch
members, coffee/tea bar, wine hour
11. Hyatt at The Bellevue
200 South Broad Street
8 Blocks
N/A
$245
Yes
Free Wi-Fi, 20% off food and
beverage in XIX Café and Restaurant
12. Le Meridien Philadelphia
1421 Arch Street
1 Block
$259
3/30/12
$275
No
Free Wi-Fi, drawing for dinner for two
1 Block
$215
4/6/12
$225
No
coffee vouchers, daily drawing for
dinner for two, daily drawing for
complimentary spa treatment
14. Philadelphia Marriott Downtown
1201 Market Street
Adjacent
N/A
$239
No
Daily drawing for dinner for two
15. Radisson Plaza-Warwick
Hotel Philadelphia
1701 S. Locust Street
11 Blocks
$175
4/14/12
$185
Yes
Free Wi-Fi, local calls, daily bottled
water, complimentary coffee vouchers,
daily drawing for dinner for two
16. Residence Inn by Marriott
1 East Penn Square
2 Blocks
N/A
$229
No
continental breakfast
17. Ritz-Carlton Philadelphia
10 Avenue of the Arts
4 Blocks
N/A
$254
Yes
Free Wi-Fi, local calls, shoe shine
18. Sheraton Philadelphia Downtown
201 North 17th Street
4 Blocks
$183 – 4 night
minimum required 3/30/12
$193
Yes
Free Wi-Fi, complimentary coffee
vouchers, daily drawing for dinner for
two
19. Sofitel Philadelphia
9 Blocks
$215
4/11/12
$219
Yes
Free Wi-Fi
20. Westin Philadelphia
6 Blocks
$259
6/1/12
$269
Yes
Free Wi-Fi, local calls, daily drawing
for dinner for two, daily drawing for
two-night complimentary stay
DIA 2012 HOTELS
1. Courtyard by Marriott
Philadelphia Downtown
21 N. Juniper Street
5. Four Points by
Sheraton Center City
1201 Race Street
6. Four Seasons Hotel Philadelphia
One Logan Square
13. Loews Philadelphia Hotel
1200 Market Street
AMENITIES
* Hotel rates do not include 15.2% tax.
**Shuttle service will be provided in the morning and end of day to guests staying at designated DIA hotels. Mid-day service will not be available.
DIA 2012 ATTENDEE REGISTRATION FORM
48th Annual Meeting | June 24 - 28, 2012 | Pennsylvania Convention Center, Philadelphia, PA | Event #12001
Attendees may register online at www.diahome.org/dia2012.
Online registration is not available to speakers or exhibitors. All registrations received at the DIA office in Horsham, PA, USA by 5:00 pm EST on
May 18, 2012 will be included in the Advance Registration Attendee List.
Full-meeting Registration (attendance of 2 or more days) includes admission to all sessions, exhibits, coffee breaks, luncheons and receptions. If DIA cannot verify your membership,
you will be charged the nonmember fee. All fees are in US dollars.
All member and nonmember fees below include access
to all available postmeeting audio synchronized
Power Point presentations.
Preconference program/Tutorials
Visit www.diahome.org/dia2012/tutorials for topics and fees. Space is limited and
preregistration is encouraged. Please indicate the tutorial # and fee.
Tutorial # _______
Tutorial # _______
Fee __________
Fee __________
Subtotal _____________
Payment options: Register online at www.diahome.org/dia2012 or by:
q Credit Card Complete this form and fax to +1.215.442.6199 or mail to: Drug Information
Association, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA. Non-U.S.
credit card payment is subject to the currency conversion rate at the time of the charge.
q Visa
q MC
q AMEX
Exp Date ________________________________
Card # __________________________________________________________________
Name (printed) ___________________________________________________________
Signature _______________________________________________________________
Member Standard
q Check drawn on a US bank payable to and mailed along with this form to: Drug Information
(available on nondiscount member standard fee only)
• Members registering after FEB. 29, 2012
US $1350 q
Nonmember Standard
US $1490 q
Nonmember fee includes a one-year membership option.
Please indicate your preference below.
q I DO want DIA membership
Association Inc., P.O. Box 95000-1240, Philadelphia, PA 19195-1240, USA. Please include a
copy of this registration form to facilitate identification of attendee.
q BANK TRANSFER Upon completion of your registration, DIA will send an email to the
address on the form with instructions on how to complete the Bank Transfer. Payment should
be made in US dollars. Your name, company, and Event I.D. #11001 must be included on the
transfer document to ensure payment to your account.
q I DO NOT want DIA membership
Join DIA now to qualify for all the benefits of membership for one year!
Discount Fees
MemberNonmember
Government (full-time)*
US $480 q
Charitable Nonprofit/Academia (full-time)
US $875 q US $1,015 q
US $620 q
If paying a nonmember fee, please check preferred membership option above.
Last Name
First Name
q Dr. q Mr. q Ms.
Degrees
Position
*Government rate is subject to eligibility requirements. Identification and proof of
eligibility will be required on site. Failure to provide proof of eligibility/ID upon request
will require paying the higher standard registration fee.
Company
One-day registration fees Mailing Address (as required for postal delivery to your location)
MemberNonmember
You must indicate which day you plan to attend. US $825
q
US $965 q
q MON, June 25 q TUES, June 26 q WED, June 27 q THUR, June 28
One-day attendees will receive access to post-meeting presentations for that day ONLY.
** If paying a nonmember fee, please indicate your membership preference above.
total payment due
Include all applicable fees
US $ __________________
A student rate of $250 is available. Contact [email protected] for
eligibility requirements and a student rate application form. Also available is an
Executive Program: Pioneering Partnerships.
Contact [email protected] for more information and a registration form.
Cancellation Policy
M.I.
Mail Stop
CityState
Zip/Postal Code
Country
email Address (required for confirmation)
Telephone Number Fax Number (required for confirmation)
All cancellations must be received in writing at DIA’s office by 5:00 pm, June 8, 2012.
If you do not cancel by June 8, 2012 and do not attend, you are responsible for
the full applicable fee. Registrants are responsible for cancelling their airline
and hotel reservations. You may transfer your registration to a colleague at
any time but membership is not transferable. Please notify DIA of any such
substitutions as soon as possible. Substitute registrants will be responsible
for the nonmember fee, if applicable. DIA reserves the right to alter the
venue, if necessary. If an event is cancelled, DIA is not responsible for any
airfare, hotel or other costs incurred by registrants. Speakers and program
agenda are subject to change.
Refunds for cancellations received in writing on or before June 8, 2012 will be:
Participants with Disabilities:
DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services
will be made available to sensory-impaired persons attending the event if requested at least 15 days
prior to event. Contact the DIA office to indicate your needs.
Photography Policy:
By attending the DIA 2012 Annual Meeting you give permission for images of you, captured during the conference through video, photo, and/or digital camera, to be used by the DIA in promotional materials, publications, and website and waive any and all rights including, but not limited to compensation or ownership.
• Full Meeting
Government/Nonprofit/Academia:
Refund Amount = Registration fee paid minus $100
All Others: Refund Amount = Registration fee paid minus $200
• Preconference Program/Tutorials – R
efund Amount = Registration fee paid minus $75
• One-day Registration – NO REFUNDS
•Cancelling any portion of your program registration will void any multiple purchase
discounts that may have been applied.
DIA 2012
48th Annual Meeting | June 24-28, 2012
PA Convention Center, Philadelphia, PA | Event #12001
Already Registered? ADD A PRECONFERENCE PROGRAM/TUTORIAL
to Your Existing Registration
This registration form should be used by attendees, speakers, program committee members, or exhibitors who wish
to add a Preconference Program /Tutorial to an existing registration. This form must be completed and submitted for
EACH preregistered person who wishes to add a Preconference Program /Tutorial to their existing registration.
Please fax this completed form to +1.215.442.6199
YES, I am registered for DIA 2012 and I would like to add
PAYMENT OPTIONS: Register online at
the following preconference program/tutorial to my
registration.
I am registered as:
CREDIT CARD Complete this form and fax to +1.215.442.6199 or mail to:
Attendee Speaker
Session, Forum, Symposium, or Workshop Chair
Exhibitor (Full Meeting or Booth Personnel)
Program Committee Member TUTORIALS
Visit www.diahome.org/dia2012/tutorials for topics and fees,
Space is limited and preregistration is encouraged.
Please indicate the ID # and fee for tutorials you plan to attend.
Tutorial # _______
Fee __________
Tutorial # _______
Fee __________
Drug Information Association, 800 Enterprise Road, Suite 200, Horsham,
PA 19044-3595, USA. Non-U.S. credit card payment is subject to the currency
conversion rate at the time of the charge.
Visa
MC
AMEX
Exp Date ________________________
Card # __________________________________________________________
Name (printed) __________________________________________________
Signature __________________________________________________
CHECK drawn on a US bank payable to and mailed along with this form to:
Drug Information Association Inc., P.O. Box 95000-1240, Philadelphia, PA
19195-1240, USA. Please include a copy of this registration form to facilitate
identification of attendee.
BANK TRANSFER Upon completion of your registration, DIA will send an
email to the address on the form with instructions on how to complete the
Bank Transfer. Payment should be made in US dollars. Your name, company,
and Event I.D. #12001 must be included on the transfer document to ensure
payment to your account.
Last Name
Subtotal
www.diahome.org or by:
First Name
US $ _________________
Dr. Mr. Ms.
Degrees
SAFE BioPharma
“Trusted Identities For Cloud Collaboration”
APCR
“Win-Win Strategies for the Sponsor-Investigator Relationship”
CANCELLED
Position
US $755
Company
US $399
Mailing Address (as required for postal delivery to your location)
TOTAL PAYMENT DUE
Mail Stop
US $ _________________
City
DIA event facilities and overnight accommodations are accessible to persons with
disabilities. Services will be made available to sensory-impaired persons attending
the event if requested at least 15 days prior to event. Contact the DIA office to indicate
your needs.
Photography Policy:
By attending the DIA 48th Annual Meeting, you give permission for images of you,
captured during the conference through video, photo, and/or digital camera, to be
used by the DIA in promotional materials, publications, and website and waive any
and all rights including, but not limited to compensation or ownership.
CANCELLATION POLICY
M.I.
Zip/Postal Code
State
Country
email Address (required for confirmation)
Telephone Number
Fax Number (required for confirmation)
All cancellations must be received in writing at DIA’s office by 5:00 pm, JUNE 8, 2012.
If you do not cancel by JUNE 8, 2012 and do not attend, you are responsible
for the full applicable fee. Registrants are responsible for cancelling their
airline and hotel reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of
any such substitutions as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable. DIA reserves the right to
alter the venue, if necessary. If an event is cancelled, DIA is not responsible
for any airfare, hotel or other costs incurred by registrants. Speakers and
program agenda are subject to change.
Refunds for cancellations received in writing ON OR BEFORE JUNE 8, 2012 will be:
• Full Meeting
Government/Nonprofit/Academia:
Refund Amount = Registration fee paid minus $100
All Others: Refund Amount = Registration fee paid minus $200
• Preconference Program/Tutorial – Refund Amount = Registration fee paid minus $75
• One-day Registration – NO REFUNDS
•Cancelling any portion of your program registration will void any multiple purchase
discounts that may have been applied.
DIA 2012 EXHIBIT PERSONNEL REGISTRATION FORM
Online registration is NOT available to exhibit personnel.
If registering for tutorials and paying by credit card, return this completed form to DIA by fax to
+1.215.442.6199 or by mail to 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA.
If paying by check, follow instructions under Payment Methods below.
DIA 2012
48 Annual Meeting
TH
Pennsylvania Convention
Center, Philadelphia, PA
ID # 12001
June 24 - 28, 2012
Completed form
should be faxed to
All registrations received at the DIA office in Horsham, PA, USA by 5:00 pm on May 18, 2012 will
be included in the Advance Registration Attendee List.
Each 10’ x 10’ booth includes: one (1) complimentary full-meeting registration and three (3)
exhibit booth personnel registrations.
Please fill out a separate form for each exhibitor registrant.
+1.215.442.6199
To expedite your registration, please check the appropriate category:
Complimentary Full-meeting Registration
Exhibit Booth Personnel
Please Note: This page must be
Once you have utilized the four (4) badges provided per each 10’ x 10’ booth, any additional
personnel must register as an attendee (NOT as an exhibitor).
completed and submitted
for each person attending
Log on to www.diahome.org and download the ATTENDEE Registration Form,
complete and return it as per the instructions on the form.
FULL MEETING REGISTRATION (attendance of 2 or more days) includes
admission to all sessions, exhibits, coffee breaks, luncheons and receptions.
TUTORIALS
Visit www.diahome.org/dia2012/tutorials for topics and fees. Space is limited and
preregistration is encouraged. Please indicate the ID #12001 and fee for tutorials you
plan to attend.
Tutorial # _______
Tutorial # _______
Fee __________
Fee __________
Subtotal _____________
Join DIA now to qualify for all the benefits of
membership for one year! www.diahome.org
PAYMENT IS REQUIRED ONLY IF REGISTERING FOR TUTORIALS.
Please check payment method below:
CREDIT CARD Complete this form and fax to +1.215.442.6199 or mail to: Drug Information
Association, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA. Non-U.S.
credit card payment is subject to the currency conversion rate at the time of the charge.
Visa
MC
AMEX
Exp Date ________________________________
Card # __________________________________________________________________
US $175
*To qualify for the early-bird discount, registration form and accompanying payment
must be received by the applicable date above.
TOTAL PAYMENT DUE
any portion of this event.
US $ __________________
A STUDENT rate of $250 is available. Contact [email protected] for
eligibility requirements and a student rate application form.
CANCELLATION POLICY
Name (printed) ___________________________________________________________
Signature _______________________________________________________________
CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information
Association Inc., P.O. Box 95000-1240, Philadelphia, PA 19195-1240, USA. Please include a
copy of this registration form to facilitate identification of attendee.
BANK TRANSFER Upon completion of your registration, DIA will send an email to the
address on the form with instructions on how to complete the Bank Transfer. Payment should
be made in US dollars. Your name, company, and Event I.D. #12001 must be included on the
transfer document to ensure payment to your account.
All cancellations must be received in writing at DIA’s office by
5:00 pm, June 8, 2012.
If you do not cancel by June 8, 2012 and do not attend, you are responsible for
the full applicable fee. Registrants are responsible for cancelling their airline
and hotel reservations. You may transfer your registration to a colleague at
any time but membership is not transferable. Please notify DIA of any such
substitutions as soon as possible. Substitute registrants will be responsible
for the nonmember fee, if applicable. DIA reserves the right to alter the
venue, if necessary. If an event is cancelled, DIA is not responsible for any
airfare, hotel or other costs incurred by registrants. Speakers and program
agenda are subject to change.
Refunds for cancellations received in writing
ON OR BEFORE JUNE 8, 2012:
• Tutorial – Refund Amount = Registration fee paid minus $75
DIA event facilities and overnight accommodations are accessible to persons with disabilities.
Services will be made available to sensory-impaired persons attending the event if requested at
least 15 days prior to event. Contact the DIA office to indicate your needs.
Photography Policy:
By attending the DIA 2012 Annual Meeting, you give permission for images of you, captured during
the conference through video, photo, and/or digital camera, to be used by the DIA in promotional
materials, publications, and website and waive any and all rights including, but not limited to compensation or ownership.
Last Name
First Name
M.I.
Dr. Mr. Ms.
Degrees
Position
Company
Mailing Address (as required for postal delivery to your location)
Mail Stop
City
Zip/Postal Code
State
Country
email Address (required for confirmation)
Telephone Number
Fax Number (required for confirmation)
NOTES
206
DIA
Certificate
Programs
Your Professional Development Pathway
DIA Certificate Programs offer a certificate of completion to a
learner after completing the requirements for a specific program.
Benefits include:
Many courses offer Continuing Education Credits
Highly interactive program engages participants while remaining
convenient for the working professional
Expert instructors will teach you the necessary skills to excel in the
real world
Complete the program at your own pace
Enrollment in our certificate program is FREE! Fees for each
course vary based on length
For more information go to www.diahome.org/certificateprograms
Broaden your horizons.
S hare experiences
I mprove your
profession
A dvance your
career
Collaborate
with
colleagues
from around
the world
Join a SIAC!
For more information, visit
www.diahome.org.
Your FDA submission documents
are serious. So are their translations.
When translating documents for FDA submission
mission such as dossiers,
CRFs, labeling, adverse event reports, and
nd product information,
ritical need for accuracy
Corporate Translations understands the critical
Our rigorous translation process includes
ludes multiple quality
rate translations quickly
inspections, guaranteeing the most accurate
and cost-effectively. We stand by the quality
ality of our translations
by providing a certiÀcation of accuracyy with each document.
ows you to prepare your
Partnering with Corporate Translations allows
submissions with conÀdence. That·s why Corporate Translations
ranslation and linguistic
is the preferred supplier of ISO 9001 translation
validation solutions to the world·s leading life science companies.
www.corptransinc.com
om
1-855-727-6003
Translation | Back Translation | Desktop Publishing| Independent Review | Editing | Proofreading
DIA BOOTH 1838
When it comes to intuitive eDiaries, more
than 90% of patients find ours are second
to none.1
10101001010110011001100101010001010101010101010100010
01100101010010101000101000110001101010101011011101001
01000
110010101001101010101010010101110001100100
0000
01100101010111100010100
11001010101010
01010
1010101001010110101001
1000001000
00011010101010100100101011001001
010100101010
0010000100110100011000001000001010100110100010101
01000101011010101010100101010101010101010101101010010
110101010101010
101010101010101010101010101001011001
0101010010011
10101011101100111000000000000000
10110101010110
0100101011010101
01010110
0101010101010
1010110010000110
1001010
101010001010101010101010000101010010101
0100001
0000000011001101010110111010010100010110010101001101
0101010100101001100011001000000000001100101010110
11000
0011001010101010010101000010101010010
10010
0010100100000100000
010101010010
011110
010101010010101000000
0100011110
000000000101000110100101010100010
0101010100
10101010101010101010110100110010110101
010101001010
1010101010101010101010100101100101010100100101000101
01010111011
000000000000001011010101001101001
010101001
110101101110101001011010100101010101010
1100110101
000101001010101010001
1010101
00001010
100101010001100001000
11011101
0010100010101001010100110101010101001010111000110010
0000000000110010101010101100 01001101001100101010
101001010100001010101001010
000001010010000
010100110001001010101010010
01001010101010010
1010000000001010001010000000000101000101000101
010100010101101010101010010101010101010101010110101010
Our easy-to-use electronic clinical outcome assessment
(eCOA) solutions promote a positive patient experience,
enabling us to consistently generate industry leading
compliance rates. 2 Talk to us today to learn more.
Visit us at Booth 3306
1. Industry Standard Research 2012
2. Data on file
™
®
It’s all about
u!
Visit us at booth #2607
1-888-677-DATA (3232) ext. 5
www.datatrak.net
Image: colored scanning electron
micrograph (SEM) of a lung cancer cell.
Our achievements change lives. Our people inspire cures.
At Millennium: The Takeda Oncology Company located
in Cambridge, MA, “We Aspire to Cure Cancer.” As a leading
biopharmaceutical company focused on oncology, Millennium
combines the agility, ideals and camaraderie of a start-up with
the resources of Japan’s largest pharmaceutical company. The
result is an entrepreneurial culture where the priorities are quality
science and making a difference in patients’ lives and the
communities we serve.
Millennium is proud to have been recognized as one of Fortune
Magazine’s 100 Best Companies to Work For in 2011 and 2012.
©2012 Millennium Pharmaceuticals, Inc. All rights reserved.
Our people share a commitment to innovation in an environment
where individual contributions are not just valued, but rewarded.
Here you’ll enjoy outstanding benefits, a friendly, respectful
atmosphere and a culture that promotes flexibility between your
personal and professional life. Join Millennium and improve the
lives of others while living yours to the fullest.
To learn more and apply, visit: joinmillennium.com/66
Global Regulatory Intelligence
> Human Drugs > Biologics > Medical Devices > IVDs > 75 Countries & Regions
“ Tarius is our no. 1
regulatory reference
database! It minimizes
our research time for
up-to-date answers
concerning the
national requirements
across the world.”
> Authentic National Authority Documents, Continuously Updated
> 50+ Expert Summaries per countr y answering regulator y FAQ’s
> Cross-Countr y Tables enabling quick comparisons of operational details
> To learn more, go to w w w.tarius.com
Visit us at Booth #1636
Compliance
without
Complexity
>> Learn how at Booth #1125
GIVEAWAYS
EVERY HOUR!
LIVE DEMOS!
BOOTH #1125
We’re social!
Connect & share.
Visit us online at www.nextdocs.com
Now with Patient
Reimbursement Cards!
Specialized Clinical Trial Management Systems
Trial Management Organizations
and Investigator Site Networks
Maintain control across all sites in
everything from study start-up activity and
project management through site payment.
And now, create, issue, and recharge
patient reimbursement cards from within
Allegro CTMS@Network. Get visibility
and improve processes with dashboards,
streamlined workflows, and project
management tools.
Investigator Sites
and Research Groups
Get real-time visibility into study conduct
across the entire clinical trial portfolio.
Allegro CTMS@Site helps maintain the
financial health of clinical trial operations
from invoicing to payments. The system
improves efficiency and compliance with
facilitated visit management, reporting,
audit trails, document management, and
now, patient reimbursement cards.
To learn more about the Allegro family of cloud-based, easy-to-use clinical trial
management systems, visit us in BOOTH #1951.
Forte Research Systems, Inc.
Madison, Wisconsin USA
(608) 826-6002
[email protected]
http://www.ForteResearch.com/allegro
Innovating through Collaboration®
Clinical researcher, are you
your company’s competitive
advantage?
With Medidata’s cloud-based
solutions, you can be.
Innovate.
Optimize.
Lead.
Visit Booth #3101 to learn how you
can apply Medidata’s advanced
technology to transform your clinical
trial processes and enhance decision
making, concept to conclusion.
Make PharmaNet/i3, the inVentiv Health Clinical business,
your partner for global drug development solutions.
Experience the unparalleled service of our 6,500 employees in more than 30 countries, our
expanded therapeutic expertise, our strategic resourcing solutions, and our unwavering
commitment to quality. For pharmaceutical, biotechnology, generic drug, and medical
device companies of all sizes around the world — let PharmaNet|i3 work for you.
Visit us at booth #2425 to learn more about PharmaNet|i3 Strategic Resourcing.
1 609 951 6800
www.pharmanet-i3.com
Phase I-IV
Strategic Resourcing
Consulting
Bioanalytical
ANALYTICS
Find breakthroughs faster.
SAS Drug Development is globally accessible yet secure, allowing your extended research teams to share
the same clinical trial information with full compliance and control. Decide with confidence.
®
sas.com/pharma
for a free white paper
SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. © 2012 SAS Institute Inc. All rights reserved. S91005US.0512
Network with Professional Colleagues Anywhere Anytime!
DIA ConneX You
DIA’s members-only social networking-style website
is a vital resource for professionals like you looking to
connect with others in your field and improve your
job performance.
Thousands of your colleagues will be part
of DIA ConneX, so don’t get left behind.
How Can DIA ConneX Help You?
• Get answers to on-the-job
questions
• Access shared resources such
as white papers and articles
• Network with thousands of
your colleagues worldwide
Get connected at www.diahome.org/DIAconnex.
Transforming Clinical Trials through…
Our People - Innovation - Transparency
A leading global CRO, PRA provides personalized service
customized to the unique requirements of each study.
Our innovative approach, flexible service and reliable delivery
enable sponsors to achieve their long-term goals.
/ŽŽƚŚϭϭϭϯ-^ƚĂƌƚƚŚĞƚƌĂŶƐĨŽƌŵĂƟŽŶŶŽǁ͗
clearlypra.com
Have you discovered what actigraphy can do for your studies?
Discover the value of implementing actigraphy technology into your studies to achieve objective and
relevant endpoints. Learn how our comprehensive services complement your studies to minimize burden
on your site staff and subjects.
Technology. Science. Services. Experience. Find it at booth 2433.
www.actigraphy.com 1-800-685-2999 or 1-541-598-3800
Stop by booth #3417
for a chance to win an iPad
Planet integrated platform for
R&D program management
• financial planning
• project management
• team collaboration and
resource allocation
• reporting and analytics
Non-Protocol
Specific Training Libraries
Protocol Specific Training
Video Informed Consent
Supplementation
Proprietary Training Validation
Automated
Rater Qualification System
Medical & Clinical Animations
DIA Booth #2025
www.trifectamultimedical.com
www.dataformsoftware.com
Los Angeles | Indianapolis | Philadelphia | Yokohama
WHEN YOU NEED TO
SIMPLIFY YOUR MOST
COMPLEX TRIALS,
THEOREM.
Theorem provides custom solutions to
streamline your trials.
John Potthoff, PhD
President, Chief Executive Officer
EXPERT GUIDANCE FOR PERFECTLY ALIGNED TRIALS.
When planning your next drug, device, diagnostic or combination product trial, think Theorem. We apply a team of
experts with a steadfast degree of experience where you need it, every time. From start to finish, no matter the scale
or setting, we have the strategic insight you need to simplify the complex, advance your trial and prepare your
submission for success. When you need a CRO to customize solutions to get you to completion on time and within
budget, don’t give it a second thought. THINK THEOREM.
Specialist in complex Phase I-IV clinical trials
Advanced clinical analytics capabilities
P
Expertise in complex medical device and combination studies
W
1-800-290-5766
www.TheoremClinical.com
Visit us at booth #3144 at the DIA Annual Meeting.
Simplifying the most complex
CLINICAL TRIALS.
Biopharmaceuticals \\ Medical Device \\ Diagnostics
Customized In-company Training Solutions
Maximize Your Company’s
Training Budget. Bring DIA Training
In House.
Align your training needs with your business goals and objectives.
Let DIA tailor a training program to match your organization’s
needs.
Exclusive benefits of our in-company training program include:
• Expert training from professionals in the pharmaceutical
and related industries
• Quality content and delivery—all at your company location
• Courses tailored to meet your specific training objectives
• Continuing education credits
DIA is recognized throughout the life sciences community as the
definitive source for information about the discovery, development,
and life cycle management of pharmaceuticals, biotechnology, and
related health care industries. That’s why top companies around the
world trust DIA to deliver current, relevant, and effective education
and professional in-company training.
Let us design the perfect in-company training experience for you!
Visit www.diahome.org/InCompany2012 for a special limited-time
offer exclusively for DIA 2012 Annual Meeting attendees.
see you in
BOSTON
June 23-27, 2013
DIA 2013
49TH ANNUAL MEETING
Advancing Therapeutic Innovation
& Regulatory Science
Program Chair
Sandra A. Milligan, MD, JD
Vice President
Global Regulatory Therapeutic Area Head
Genentech, Inc.
Call for Abstracts
Deadline: September 12, 2012*
*deadline will not be extended
Visit www.diahome.org/dia2013
for more information

Dean Kamen

Transcription

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